Trial Outcomes & Findings for Framingham State Food Study (NCT NCT02068885)
NCT ID: NCT02068885
Last Updated: 2026-01-09
Results Overview
Total energy expenditure (TEE), assessed by indirect calorimetry using stable isotopes Total calories burned: Participants each drank about a cup of water containing special tracers which are measurable when they pass out of the body through urine. They provided a urine sample before they drank the water and then about every other day for the next two (2) weeks. Change: average (midpoint of test phase, end of test phase) - start of trial
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
234 participants
Primary outcome timeframe
Start of Trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Results posted on
2026-01-09
Participant Flow
We recruited participants by posting flyers, newspaper advertisements, and Internet announcements.
We enrolled 234 participants for the run-in phase. Of these, 164 participants achieved at least 10% weight loss and were randomly assigned to one of three diets for the test phase (low-carbohydrate diet, n=57; moderate-carbohydrate diet, n=53; or high-carbohydrate diet, n=54).
Participant milestones
| Measure |
Low Carbohydrate Diet
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
High Carbohydrate Diet
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Overall Study
STARTED
|
57
|
53
|
54
|
|
Overall Study
Provided data at midpoint test phase
|
56
|
50
|
48
|
|
Overall Study
Provided data at end of test phase
|
54
|
48
|
46
|
|
Overall Study
Included in intention-to-treat analysis
|
56
|
52
|
54
|
|
Overall Study
COMPLETED
|
54
|
48
|
46
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
8
|
Reasons for withdrawal
| Measure |
Low Carbohydrate Diet
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
High Carbohydrate Diet
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Overall Study
Withdrew
|
3
|
5
|
8
|
Baseline Characteristics
Framingham State Food Study
Baseline characteristics by cohort
| Measure |
Low Carbohydrate Diet
n=57 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=53 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
High Carbohydrate Diet
n=54 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
57 Participants
n=9 Participants
|
53 Participants
n=6 Participants
|
54 Participants
n=9 Participants
|
164 Participants
n=205 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
|
Age, Continuous
|
37.1 years
STANDARD_DEVIATION 13.3 • n=9 Participants
|
37.3 years
STANDARD_DEVIATION 14.9 • n=6 Participants
|
39.8 years
STANDARD_DEVIATION 15.1 • n=9 Participants
|
37.8 years
STANDARD_DEVIATION 14.4 • n=205 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=9 Participants
|
36 Participants
n=6 Participants
|
42 Participants
n=9 Participants
|
115 Participants
n=205 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=9 Participants
|
17 Participants
n=6 Participants
|
12 Participants
n=9 Participants
|
49 Participants
n=205 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
8 Participants
n=9 Participants
|
25 Participants
n=205 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=9 Participants
|
46 Participants
n=6 Participants
|
46 Participants
n=9 Participants
|
139 Participants
n=205 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=9 Participants
|
53 participants
n=6 Participants
|
54 participants
n=9 Participants
|
164 participants
n=205 Participants
|
|
Total Energy Expenditure
|
3110 kcal/d
STANDARD_DEVIATION 680 • n=9 Participants
|
3030 kcal/d
STANDARD_DEVIATION 788 • n=6 Participants
|
2915 kcal/d
STANDARD_DEVIATION 686 • n=9 Participants
|
3021 kcal/d
STANDARD_DEVIATION 719 • n=205 Participants
|
PRIMARY outcome
Timeframe: Start of Trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenancePopulation: Intention-to-treat analysis
Total energy expenditure (TEE), assessed by indirect calorimetry using stable isotopes Total calories burned: Participants each drank about a cup of water containing special tracers which are measurable when they pass out of the body through urine. They provided a urine sample before they drank the water and then about every other day for the next two (2) weeks. Change: average (midpoint of test phase, end of test phase) - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=54 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=56 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=52 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Total Energy Expenditure, Assessed by Indirect Calorimetry Using Stable Isotopes
Start of Trial
|
2640 kcal/d
Interval 2623.0 to 2657.0
|
2713 kcal/d
Interval 2696.0 to 2730.0
|
2504 kcal/d
Interval 2486.0 to 2522.0
|
|
Total Energy Expenditure, Assessed by Indirect Calorimetry Using Stable Isotopes
Change
|
-19 kcal/d
Interval -104.0 to 66.0
|
190 kcal/d
Interval 109.0 to 270.0
|
71 kcal/d
Interval -12.0 to 155.0
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenancePopulation: Intention-to-treat analysis
Resting energy expenditure, assessed by indirect calorimetry using respiratory gas exchange Calories burned while resting: Participants lied down with head and neck under a clear plastic "bubble," breathing room air. Gases in expired air were collected. Change: average (midpoint of test phase, end of test phase) - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=54 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=56 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=51 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Resting Energy Expenditure, Assessed by Indirect Calorimetry Using Respiratory Gas Exchange
Start of Trial
|
1603 kcal/d
Interval 1597.0 to 1609.0
|
1615 kcal/d
Interval 1609.0 to 1621.0
|
1576 kcal/d
Interval 1569.0 to 1583.0
|
|
Resting Energy Expenditure, Assessed by Indirect Calorimetry Using Respiratory Gas Exchange
Change
|
34 kcal/d
Interval 10.0 to 57.0
|
54 kcal/d
Interval 32.0 to 76.0
|
46 kcal/d
Interval 23.0 to 69.0
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenancePopulation: Intention-to-treat analysis
Actigraph Accelerometer Change: average (midpoint of test phase, end of test phase) - start of trial An Actigraph Accelerometer measures movement, similar to a pedometer. Data are reported as counts (divided by 1,000) per day. Each participant wore the the accelerometer on the right hip for 7 days at each time point.
Outcome measures
| Measure |
High Carbohydrate Diet
n=54 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=55 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=52 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Physical Activity, Assessed by Accelerometry
Start of Trial
|
476.6 counts/d
Interval 470.4 to 482.8
|
495.8 counts/d
Interval 489.5 to 502.1
|
463.8 counts/d
Interval 457.0 to 470.6
|
|
Physical Activity, Assessed by Accelerometry
Change
|
-26.3 counts/d
Interval -52.0 to -0.6
|
-6.9 counts/d
Interval -31.0 to 17.1
|
-42.4 counts/d
Interval -67.7 to -17.1
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceEfficiency is expressed as percentage ratio of power generated during cycle ergometry (with conversion of Watts to kcal/min using a factor of 0.01433) to energy expenditure above resting. Change: end of test phase - start of trial.
Outcome measures
| Measure |
High Carbohydrate Diet
n=53 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=55 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=51 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Skeletal Muscle Work Efficiency
Start of Trial
|
12.2 % power generated to energy expended
Interval 12.1 to 12.3
|
12.2 % power generated to energy expended
Interval 12.1 to 12.3
|
11.7 % power generated to energy expended
Interval 11.6 to 11.8
|
|
Skeletal Muscle Work Efficiency
Change
|
-0.1 % power generated to energy expended
Interval -0.8 to 0.5
|
0.3 % power generated to energy expended
Interval -0.3 to 0.9
|
-0.0 % power generated to energy expended
Interval -0.6 to 0.6
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss)Population: Intention-to-treat analysis
Leptin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 6) are expressed in percentage units (100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=54 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=56 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=51 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Leptin (Start of Trial)
|
10.9 ng/mL
Interval 10.5 to 11.3
|
9.6 ng/mL
Interval 9.2 to 10.0
|
9.8 ng/mL
Interval 9.4 to 10.2
|
SECONDARY outcome
Timeframe: Change through 20 weeks' weight loss maintenancePopulation: Intention-to-treat analysis
Leptin levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=54 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=56 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=51 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Leptin (% Change)
|
34.2 % change
Interval 21.8 to 47.7
|
17.9 % change
Interval 7.7 to 29.1
|
34.8 % change
Interval 22.6 to 48.2
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss)Population: Intention-to-treat analysis
Ghrelin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 8) are expressed in percentage units (100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=54 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=56 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=51 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Ghrelin (Start of Trial)
|
693.2 pg/mL
Interval 679.5 to 706.9
|
598.2 pg/mL
Interval 586.3 to 610.1
|
640.1 pg/mL
Interval 626.4 to 653.8
|
SECONDARY outcome
Timeframe: Change through 20 weeks' weight loss maintenancePopulation: Intention-to-treat analysis
Ghrelin levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=54 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=56 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=51 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Ghrelin (% Change)
|
-4.9 % change
Interval -8.4 to -1.2
|
-11.8 % change
Interval -14.8 to -8.6
|
-8.7 % change
Interval -12.0 to -5.3
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceBiomeasure of carbohydrate intake Change, 10 weeks: midpoint of test phase - start of trial Change, 20 weeks: end of test phase - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=54 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=56 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=51 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
1,5-Anhydroglucitol
Start of Trial
|
17.1 ug/mL
Interval 16.7 to 17.6
|
16.7 ug/mL
Interval 16.2 to 17.2
|
17.2 ug/mL
Interval 16.7 to 17.7
|
|
1,5-Anhydroglucitol
Change, 10 weeks
|
0.1 ug/mL
Interval -0.4 to 0.6
|
-2.5 ug/mL
Interval -3.0 to -2.0
|
-1.2 ug/mL
Interval -1.7 to -0.7
|
|
1,5-Anhydroglucitol
Change, 20 weeks
|
0.6 ug/mL
Interval -0.2 to 1.3
|
-3.5 ug/mL
Interval -4.2 to -2.8
|
-1.8 ug/mL
Interval -2.6 to -1.1
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceChange, 10 weeks: midpoint of test phase - start of trial. Change, 20 weeks: end of test phase - start of trial.
Outcome measures
| Measure |
High Carbohydrate Diet
n=54 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=56 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=51 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Glycemic Control, Assessed by HgA1c
Start of Trial
|
5.61 % hemoglobin with glucose bound
Interval 5.57 to 5.65
|
5.56 % hemoglobin with glucose bound
Interval 5.52 to 5.6
|
5.58 % hemoglobin with glucose bound
Interval 5.54 to 5.62
|
|
Glycemic Control, Assessed by HgA1c
Change, 10 weeks
|
-0.01 % hemoglobin with glucose bound
Interval -0.05 to 0.02
|
0.01 % hemoglobin with glucose bound
Interval -0.02 to 0.04
|
0.03 % hemoglobin with glucose bound
Interval 0.0 to 0.06
|
|
Glycemic Control, Assessed by HgA1c
Change, 20 weeks
|
-0.05 % hemoglobin with glucose bound
Interval -0.08 to -0.01
|
-0.01 % hemoglobin with glucose bound
Interval -0.04 to 0.03
|
0.00 % hemoglobin with glucose bound
Interval -0.03 to 0.04
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceTriglyceride levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units Change, 10 weeks: midpoint of test phase - start of trial Change, 20 weeks: end of test phase - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=54 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=56 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=51 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Triglycerides
Start of Trial
|
80.5 md/dL
Interval 74.2 to 87.4
|
77.3 md/dL
Interval 71.1 to 84.0
|
76.5 md/dL
Interval 70.2 to 83.3
|
|
Triglycerides
Change, 10 weeks
|
10.9 md/dL
Interval 2.3 to 20.2
|
-12.1 md/dL
Interval -18.5 to -5.1
|
8.4 md/dL
Interval 0.0 to 17.5
|
|
Triglycerides
Change, 20 weeks
|
7.5 md/dL
Interval -1.7 to 17.6
|
-12.8 md/dL
Interval -19.8 to -5.2
|
-0.1 md/dL
Interval -8.5 to 9.1
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenancePopulation: Intention-to-treat analysis
Body fat, presented as a % of total mass Participants each had a special scan (x-ray) to measure their amount of body fat. The special x-ray is called "dual-energy x-ray absorptiometry" (DXA). They were asked to lie still on a table for x-ray pictures. Change: end of test phase - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=54 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=56 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=52 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Body Composition (DXA)
Start of Trial
|
37.8 % of total body mass
Interval 36.2 to 39.4
|
36.2 % of total body mass
Interval 34.6 to 37.9
|
37.3 % of total body mass
Interval 35.1 to 39.5
|
|
Body Composition (DXA)
Change
|
-0.5 % of total body mass
Interval -1.0 to -0.1
|
-0.3 % of total body mass
Interval -0.7 to 0.2
|
-0.3 % of total body mass
Interval -0.7 to 0.1
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenancePopulation: Intention-to-treat analysis
Glucose level, fasting blood draw Change: end of test phase - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=54 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=56 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=52 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Glucose
Start of Trial
|
95.1 mg/dL
Interval 92.9 to 97.3
|
95.1 mg/dL
Interval 92.9 to 97.2
|
94.3 mg/dL
Interval 91.9 to 96.8
|
|
Glucose
Change
|
-1.0 mg/dL
Interval -3.0 to 0.9
|
1.0 mg/dL
Interval -0.9 to 2.8
|
-0.3 mg/dL
Interval -2.2 to 1.7
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenancePopulation: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
Lipoprotein insulin resistance (LPIR) score was calculated from triglyceride-rich, high-density, and low-density lipoprotein particle (TRL-P, HDL-P, LDL-P) sizes and subfraction concentrations (large/very large TRL-P, large HDL-P, small LDL-P). LPIR score is quantified on a scale of 0-100. Higher scores indicate worse outcome. Change: end of test phase - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=46 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=53 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=48 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Change in Lipoprotein Particle Subfraction Distribution
Start of trial
|
31.4 score on a scale (0-100)
Interval 26.9 to 35.9
|
34.6 score on a scale (0-100)
Interval 28.7 to 40.5
|
31.5 score on a scale (0-100)
Interval 26.1 to 36.9
|
|
Change in Lipoprotein Particle Subfraction Distribution
Change
|
3.6 score on a scale (0-100)
Interval -0.6 to 7.7
|
-5.3 score on a scale (0-100)
Interval -9.2 to -1.5
|
-0.02 score on a scale (0-100)
Interval -4.1 to 4.1
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenancePopulation: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
Change: end of test phase - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=46 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=53 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=48 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Total Cholesterol
Change
|
16.2 mg/dL
Interval 11.2 to 21.1
|
16.1 mg/dL
Interval 11.5 to 20.7
|
18.5 mg/dL
Interval 13.6 to 23.3
|
|
Total Cholesterol
Start of trial
|
142.9 mg/dL
Interval 135.1 to 150.8
|
147.5 mg/dL
Interval 140.2 to 154.9
|
145.5 mg/dL
Interval 136.1 to 154.8
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceHigh-density lipoprotein cholesterol Change, 10 weeks: midpoint of test phase - start of trial. Change, 20 weeks: end of test phase - start of trial.
Outcome measures
| Measure |
High Carbohydrate Diet
n=54 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=56 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=51 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
HDL-Cholesterol
Start of Trial
|
47.6 md/dL
Interval 45.5 to 49.6
|
47.8 md/dL
Interval 45.7 to 49.8
|
49.1 md/dL
Interval 47.0 to 51.2
|
|
HDL-Cholesterol
Change, 10 weeks
|
4.7 md/dL
Interval 2.9 to 6.5
|
11.1 md/dL
Interval 9.4 to 12.8
|
6.9 md/dL
Interval 5.1 to 8.7
|
|
HDL-Cholesterol
Change, 20 weeks
|
6.8 md/dL
Interval 4.7 to 8.9
|
13.0 md/dL
Interval 11.0 to 15.0
|
9.7 md/dL
Interval 7.6 to 11.8
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenancePopulation: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
Calculated by subtracting HDL-cholesterol from total cholesterol. Change: end of test phase - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=46 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=53 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=48 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Non-HDL-Cholesterol
Change
|
9.5 mg/dL
Interval 4.6 to 14.4
|
6.3 mg/dL
Interval 1.8 to 10.9
|
11.0 mg/dL
Interval 6.3 to 15.8
|
|
Non-HDL-Cholesterol
Start of trial
|
98.2 mg/dL
Interval 91.2 to 105.3
|
101.5 mg/dL
Interval 94.1 to 108.9
|
99.0 mg/dL
Interval 90.6 to 107.5
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenancePopulation: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
Low-density-lipoprotein cholesterol Change: end of test phase - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=46 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=53 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=48 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
LDL-Cholesterol
Start of trial
|
79.5 mg/dL
Interval 73.2 to 85.8
|
80.6 mg/dL
Interval 75.1 to 86.1
|
77.6 mg/dL
Interval 70.3 to 84.9
|
|
LDL-Cholesterol
Change
|
8.2 mg/dL
Interval 4.2 to 12.2
|
10.0 mg/dL
Interval 6.3 to 13.7
|
11.7 mg/dL
Interval 7.8 to 15.7
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss)Population: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
Total and high molecular weight adiponectin Adiponectin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 20) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=46 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=53 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=48 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Adiponectin (Start of Trial)
Total
|
4.9 ng/mL
Interval 3.5 to 5.9
|
4.0 ng/mL
Interval 3.0 to 5.9
|
5.1 ng/mL
Interval 3.3 to 7.2
|
|
Adiponectin (Start of Trial)
High Molecular Weight
|
2.7 ng/mL
Interval 1.9 to 3.6
|
2.3 ng/mL
Interval 1.4 to 3.5
|
2.8 ng/mL
Interval 1.6 to 4.2
|
SECONDARY outcome
Timeframe: Change through 20 weeks' weight loss maintenancePopulation: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
Adiponeptin levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=46 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=53 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=48 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Adiponectin (% Change)
Total
|
23.0 % change
Interval 14.5 to 32.3
|
33.6 % change
Interval 24.9 to 42.9
|
17.4 % change
Interval 9.4 to 26.0
|
|
Adiponectin (% Change)
High Molecular Weight
|
27.8 % change
Interval 18.7 to 37.7
|
42.9 % change
Interval 33.3 to 53.1
|
27.6 % change
Interval 18.6 to 37.2
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss)Population: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
C-reactive protein, marker of inflammation C-reactive protein levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 22) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=46 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=53 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=48 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
C-reactive Protein (Start of Trial)
|
1.5 mg/L
Interval 0.6 to 3.1
|
1.1 mg/L
Interval 0.6 to 2.5
|
1.5 mg/L
Interval 0.7 to 4.6
|
SECONDARY outcome
Timeframe: Change through 20 weeks' weight loss maintenancePopulation: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
C-reactive protein, marker of inflammation C-reactive protein levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=46 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=53 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=48 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
C-reactive Protein (% Change)
|
-1.7 % change
Interval -18.6 to 18.6
|
-9.9 % change
Interval -24.2 to 7.1
|
-20.6 % change
Interval -33.8 to -4.8
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss)Population: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
Interleukin-6, marker of inflammation Interleukin-6 levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 24) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=46 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=53 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=48 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
IL-6 (Start of Trial)
|
1.7 pg/mL
Interval 1.0 to 2.6
|
1.4 pg/mL
Interval 1.0 to 2.4
|
1.8 pg/mL
Interval 1.1 to 3.3
|
SECONDARY outcome
Timeframe: Change through 20 weeks' weight loss maintenancePopulation: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
Interleukin-6, marker of inflammation Interleukin-6 levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=46 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=53 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=48 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
IL-6 (% Change)
|
-18.3 % change
Interval -31.8 to -2.2
|
-23.6 % change
Interval -35.4 to -9.6
|
-20.1 % change
Interval -33.0 to -4.7
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenancePopulation: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
Systolic and diastolic blood pressure Change: end of test phase - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=46 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=53 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=48 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Blood Pressure
Diastolic, Change
|
2.2 mmHg
Interval -0.6 to 5.0
|
2.2 mmHg
Interval -0.4 to 4.8
|
1.4 mmHg
Interval -1.3 to 4.1
|
|
Blood Pressure
Systolic, Start of trial
|
114.3 mmHg
Interval 111.8 to 116.9
|
117.2 mmHg
Interval 114.7 to 119.7
|
119.2 mmHg
Interval 115.9 to 122.5
|
|
Blood Pressure
Systolic, Change
|
1.8 mmHg
Interval -1.3 to 5.0
|
-1.5 mmHg
Interval -4.4 to 1.5
|
0.0 mmHg
Interval -3.1 to 3.1
|
|
Blood Pressure
Diastolic, Start of trial
|
70.5 mmHg
Interval 68.3 to 72.7
|
70.7 mmHg
Interval 68.3 to 73.1
|
73.7 mmHg
Interval 71.3 to 76.0
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss)Population: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
Plasminogen activator inhibitor-1 levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 27) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=46 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=53 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=48 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Plasminogen Activator Inhibitor-1 (Start of Trial)
|
1.2 ng/mL
Interval 0.6 to 2.1
|
1.1 ng/mL
Interval 0.7 to 2.5
|
1.5 ng/mL
Interval 0.7 to 3.1
|
SECONDARY outcome
Timeframe: Change through 20 weeks' weight loss maintenancePopulation: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
Plasminogen activator inhibitor-1 levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=46 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=53 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=48 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Plasminogen Activator Inhibitor-1 (% Change)
|
14.9 % change
Interval -10.1 to 46.9
|
7.2 % change
Interval -14.7 to 34.8
|
26.9 % change
Interval -0.2 to 61.4
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenancePopulation: Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism).
Change: end of test phase - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=46 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=53 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=48 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Fibrinogen
Start of trial
|
428.1 mg/dL
Interval 400.9 to 455.2
|
421.1 mg/dL
Interval 398.2 to 443.9
|
461.0 mg/dL
Interval 430.7 to 491.4
|
|
Fibrinogen
Change
|
-21.7 mg/dL
Interval -42.9 to -0.5
|
-17.0 mg/dL
Interval -36.8 to 2.7
|
-22.4 mg/dL
Interval -43.2 to -1.7
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss)Population: Descriptive data, reflecting participant flow Pre-weight loss (N=162, minus 1 participant in the Moderate carbohydrate diet group for whom insulin-30 result is missing) Start of trial (N=162) End of test phase (N=148, minus 1 participant in the High carbohydrate diet group for whom insulin-30 result is missing)
Insulin level 30 minutes after consuming 75 grams of glucose
Outcome measures
| Measure |
High Carbohydrate Diet
n=54 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=56 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=52 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Insulin Secretion Determined as Blood Insulin Concentration 30 Minutes After Oral Glucose (Start of Trial)
Pre-weight loss
|
99.2 mIU/L
Interval 73.7 to 153.4
|
131.4 mIU/L
Interval 77.6 to 173.5
|
116.7 mIU/L
Interval 86.8 to 218.5
|
|
Insulin Secretion Determined as Blood Insulin Concentration 30 Minutes After Oral Glucose (Start of Trial)
Start of trial
|
68.0 mIU/L
Interval 57.0 to 106.6
|
95.9 mIU/L
Interval 55.5 to 131.3
|
79.9 mIU/L
Interval 56.1 to 143.3
|
|
Insulin Secretion Determined as Blood Insulin Concentration 30 Minutes After Oral Glucose (Start of Trial)
End of test phase
|
74.8 mIU/L
Interval 53.1 to 109.9
|
96.2 mIU/L
Interval 50.5 to 134.0
|
74.5 mIU/L
Interval 51.3 to 135.4
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenancePopulation: Descriptive data, reflecting participant flow End of test phase (N=148, completers)
thyroid function test
Outcome measures
| Measure |
High Carbohydrate Diet
n=46 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=54 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=48 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Thyroxine (T4)
Pre-weight loss
|
90 nmol/L
Interval 79.0 to 102.0
|
85 nmol/L
Interval 78.0 to 95.0
|
86 nmol/L
Interval 78.0 to 97.0
|
|
Thyroxine (T4)
Start of trial
|
86 nmol/L
Interval 78.0 to 96.0
|
84 nmol/L
Interval 75.0 to 96.0
|
85 nmol/L
Interval 80.0 to 93.0
|
|
Thyroxine (T4)
End of test phase
|
85 nmol/L
Interval 77.0 to 98.0
|
85 nmol/L
Interval 78.0 to 94.0
|
86 nmol/L
Interval 80.0 to 98.0
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenancePopulation: Descriptive data, reflecting participant flow End of test phase (N=148, completers)
free thyroxine, thyroid function test
Outcome measures
| Measure |
High Carbohydrate Diet
n=46 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=54 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=48 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Free T4
Pre-weight loss
|
14.8 pmol/L
Interval 13.5 to 16.1
|
14.3 pmol/L
Interval 13.1 to 15.9
|
15.0 pmol/L
Interval 13.9 to 16.4
|
|
Free T4
Start of trial
|
15.0 pmol/L
Interval 14.1 to 15.8
|
14.9 pmol/L
Interval 13.6 to 15.9
|
15.2 pmol/L
Interval 15.0 to 16.9
|
|
Free T4
End of test phase
|
15.2 pmol/L
Interval 14.0 to 16.1
|
15.4 pmol/L
Interval 14.0 to 16.6
|
15.7 pmol/L
Interval 14.7 to 17.2
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenancePopulation: Descriptive data, reflecting participant flow End of test phase (N=148, completers)
Produced by the pituitary gland in the brain. Tells the thyroid gland to make thyroid hormones.
Outcome measures
| Measure |
High Carbohydrate Diet
n=46 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=54 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=48 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Thyroid Stimulating Hormone
Pre-weight loss
|
2.1 ulU/ml
Interval 1.3 to 3.2
|
2.0 ulU/ml
Interval 1.6 to 2.6
|
1.8 ulU/ml
Interval 1.4 to 2.5
|
|
Thyroid Stimulating Hormone
Start of trial
|
2.5 ulU/ml
Interval 1.7 to 3.0
|
2.1 ulU/ml
Interval 1.5 to 2.9
|
2.2 ulU/ml
Interval 1.5 to 2.7
|
|
Thyroid Stimulating Hormone
End of test phase
|
2.1 ulU/ml
Interval 1.4 to 3.5
|
2.0 ulU/ml
Interval 1.5 to 2.5
|
1.7 ulU/ml
Interval 1.4 to 2.7
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenancePopulation: Descriptive data, reflecting participant flow End of test phase (N=148, completers minus 1 participant in the High carbohydrate diet group for whom reverse T3 result is missing)
thyroid function test, inactive form of triiodothyronine (T3) Lifespan Bio kit was used for analysis. The range of this kit is 250 to 5000 pg/mL, which varies from other commercially available kits (about 10-fold greater values).
Outcome measures
| Measure |
High Carbohydrate Diet
n=45 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=54 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=48 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Reverse T3
Pre-weight loss
|
1536 pg/mL
Interval 1410.0 to 1756.0
|
1499 pg/mL
Interval 1306.0 to 1610.0
|
1548 pg/mL
Interval 1429.0 to 1676.0
|
|
Reverse T3
Start of trial
|
1548 pg/mL
Interval 1378.0 to 1733.0
|
1545 pg/mL
Interval 1356.0 to 1687.0
|
1554 pg/mL
Interval 1383.0 to 1768.0
|
|
Reverse T3
End of test phase
|
1546 pg/mL
Interval 1332.0 to 1686.0
|
1557 pg/mL
Interval 1375.0 to 1702.0
|
1572 pg/mL
Interval 1404.0 to 1795.0
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenancePopulation: Descriptive data, reflecting participant flow End of test phase (N=148, completers)
cortisol (stress hormone) excreted in the urine over a 24-hour period
Outcome measures
| Measure |
High Carbohydrate Diet
n=46 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=54 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=48 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Urinary Cortisol Excretion
Pre-weight loss
|
63 μg/d
Interval 45.0 to 91.0
|
61 μg/d
Interval 48.0 to 78.0
|
59 μg/d
Interval 41.0 to 80.0
|
|
Urinary Cortisol Excretion
Start of trial
|
63 μg/d
Interval 50.0 to 77.0
|
66 μg/d
Interval 48.0 to 83.0
|
64 μg/d
Interval 47.0 to 88.0
|
|
Urinary Cortisol Excretion
End of test phase
|
64 μg/d
Interval 45.0 to 84.0
|
78 μg/d
Interval 56.0 to 100.0
|
64 μg/d
Interval 50.0 to 94.0
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenancePopulation: Descriptive data, reflecting participant flow End of test phase (N=148, completers)
catecholamine excreted in the urine over 24 hours, also known as epinephrine
Outcome measures
| Measure |
High Carbohydrate Diet
n=46 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=54 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=48 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Urinary Catecholamine - Adrenaline
Pre-weight loss
|
2.9 mcg/day
Interval 2.2 to 3.6
|
3.1 mcg/day
Interval 2.4 to 4.1
|
3.0 mcg/day
Interval 2.2 to 4.2
|
|
Urinary Catecholamine - Adrenaline
Start of trial
|
3.0 mcg/day
Interval 2.2 to 3.5
|
3.5 mcg/day
Interval 2.7 to 4.7
|
3.2 mcg/day
Interval 2.3 to 4.3
|
|
Urinary Catecholamine - Adrenaline
End of test phase
|
3.1 mcg/day
Interval 2.3 to 4.1
|
3.6 mcg/day
Interval 2.6 to 5.3
|
3.4 mcg/day
Interval 2.3 to 4.7
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenancePopulation: Descriptive data, reflecting participant flow End of test phase (N=148, completers)
catecholamine excreted in the urine over 24 hours
Outcome measures
| Measure |
High Carbohydrate Diet
n=46 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=54 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=48 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Urinary Catecholamine - Dopamine
Pre-weight loss
|
117.8 mcg/day
Interval 92.7 to 163.6
|
142.0 mcg/day
Interval 105.7 to 187.5
|
143.2 mcg/day
Interval 83.2 to 187.8
|
|
Urinary Catecholamine - Dopamine
Start of trial
|
104.7 mcg/day
Interval 76.0 to 125.9
|
112.9 mcg/day
Interval 75.1 to 157.6
|
112.4 mcg/day
Interval 85.7 to 135.3
|
|
Urinary Catecholamine - Dopamine
End of test phase
|
104.7 mcg/day
Interval 83.9 to 141.7
|
123.0 mcg/day
Interval 86.4 to 159.1
|
112.9 mcg/day
Interval 90.5 to 156.6
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenancePopulation: Descriptive data, reflecting participant flow End of test phase (N=148, completers)
catecholamine excreted in the urine over 24 hours, also known as norepinephrine
Outcome measures
| Measure |
High Carbohydrate Diet
n=46 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=54 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=48 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Urinary Catecholamine - Noradrenaline
Pre-weight loss
|
25.3 mcg/day
Interval 19.8 to 31.1
|
25.8 mcg/day
Interval 18.9 to 34.2
|
23.9 mcg/day
Interval 18.9 to 31.6
|
|
Urinary Catecholamine - Noradrenaline
Start of trial
|
24.7 mcg/day
Interval 17.5 to 30.5
|
25.2 mcg/day
Interval 19.4 to 31.6
|
25.3 mcg/day
Interval 20.1 to 31.7
|
|
Urinary Catecholamine - Noradrenaline
End of test phase
|
26.0 mcg/day
Interval 19.5 to 32.4
|
27.4 mcg/day
Interval 18.8 to 36.1
|
26.1 mcg/day
Interval 20.6 to 36.9
|
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Ad libitum feeding period (weeks 21 and 22 following randomization)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceCalifornia Verbal Learning Test - Second Edition \[CVLT-II\] and Digit Span Test
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceTrail Making Test Parts A and B \[TMT-A, TMT-B\]
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceBeck Depression Inventory-II \[BDI-II\]
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceMood and Anxiety Symptom Questionnaire \[MASQ\]
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceYale Food Addiction Scale \[YFAS\]
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceEmotional Eating Scale \[EES\]
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceBinge Eating Scale \[BES\]
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenancePopulation: The outcome is "Effect Modification by Insulin Secretion." Thus,participants were divided into tertiles of Insulin-30. Tertile I: Low=17, Moderate=16, High=22 Tertile II: Low=15, Moderate=22, High=17 Tertile III: Low=24, Moderate=14, High=15
Effect modifier: Insulin level 30 minutes into an standard OGTT (Insulin-30) Outcome: Total Energy Expenditure Tertiles: Pre-weight-loss Insulin-30 (Low, Moderate, High) Change: average (midpoint of test phase, end of test phase) - start of trial
Outcome measures
| Measure |
High Carbohydrate Diet
n=54 Participants
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Low Carbohydrate Diet
n=56 Participants
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
Moderate Carbohydrate Diet
n=52 Participants
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
|
|---|---|---|---|
|
Effect Modification by Insulin Secretion of Metabolic Responses to Diet
Start of Trial, Low Insulin-30
|
2647 kcal/d
Interval 2463.0 to 2832.0
|
2795 kcal/d
Interval 2591.0 to 2998.0
|
2673 kcal/d
Interval 2456.0 to 2891.0
|
|
Effect Modification by Insulin Secretion of Metabolic Responses to Diet
Change, High Insulin-30
|
-37 kcal/d
Interval -201.0 to 127.0
|
271 kcal/d
Interval 145.0 to 396.0
|
141 kcal/d
Interval -20.0 to 303.0
|
|
Effect Modification by Insulin Secretion of Metabolic Responses to Diet
Change, Low Insulin-30
|
15 kcal/d
Interval -119.0 to 148.0
|
147 kcal/d
Interval -1.0 to 295.0
|
103 kcal/d
Interval -44.0 to 250.0
|
|
Effect Modification by Insulin Secretion of Metabolic Responses to Diet
Start of Trial, Moderate Insulin-30
|
2782 kcal/d
Interval 2571.0 to 2993.0
|
2816 kcal/d
Interval 2597.0 to 3035.0
|
2563 kcal/d
Interval 2377.0 to 2750.0
|
|
Effect Modification by Insulin Secretion of Metabolic Responses to Diet
Change, Moderate Insulin-30
|
-50 kcal/d
Interval -200.0 to 101.0
|
114 kcal/d
Interval -37.0 to 266.0
|
-5 kcal/d
Interval -136.0 to 127.0
|
|
Effect Modification by Insulin Secretion of Metabolic Responses to Diet
Start of Trial, High Insulin-30
|
2544 kcal/d
Interval 2331.0 to 2757.0
|
2643 kcal/d
Interval 2461.0 to 2826.0
|
2281 kcal/d
Interval 2053.0 to 2508.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Start of (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenanceOutcome measures
Outcome data not reported
Adverse Events
Run-in Phase
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Low Carbohydrate Diet
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Moderate Carbohydrate Diet
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
High Carbohydrate Diet
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Run-in Phase
n=234 participants at risk
Pre-randomization: During the run-in phase, energy intake was restricted to promote 12% (within 2%) weight loss over 9-10 weeks.
|
Low Carbohydrate Diet
n=57 participants at risk
Feeding study: Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein.
|
Moderate Carbohydrate Diet
n=53 participants at risk
Feeding study: Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein.
|
High Carbohydrate Diet
n=54 participants at risk
Feeding study: Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
|
|---|---|---|---|---|
|
Surgical and medical procedures
Laparoscopic cholecystectomy
|
0.00%
0/234 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/57 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/53 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
1.9%
1/54 • Number of events 1 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
|
Reproductive system and breast disorders
Removal of intrauterine device
|
0.00%
0/234 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/57 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/53 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
1.9%
1/54 • Number of events 1 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
Other adverse events
| Measure |
Run-in Phase
n=234 participants at risk
Pre-randomization: During the run-in phase, energy intake was restricted to promote 12% (within 2%) weight loss over 9-10 weeks.
|
Low Carbohydrate Diet
n=57 participants at risk
Feeding study: Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein.
|
Moderate Carbohydrate Diet
n=53 participants at risk
Feeding study: Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein.
|
High Carbohydrate Diet
n=54 participants at risk
Feeding study: Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.43%
1/234 • Number of events 1 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/57 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/53 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/54 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
|
Immune system disorders
Food allergy, aversion or intolerance
|
1.7%
4/234 • Number of events 4 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
3.5%
2/57 • Number of events 2 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
3.8%
2/53 • Number of events 2 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
1.9%
1/54 • Number of events 1 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.43%
1/234 • Number of events 1 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/57 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/53 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/54 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
|
General disorders
Mood changes
|
0.43%
1/234 • Number of events 1 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/57 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/53 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/54 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
|
Metabolism and nutrition disorders
Increased blood cholesterol
|
0.43%
1/234 • Number of events 1 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/57 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/53 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/54 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
|
General disorders
Possible gall bladder disease
|
0.43%
1/234 • Number of events 1 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/57 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/53 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/54 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
|
Endocrine disorders
Possible hypoglycemia
|
0.43%
1/234 • Number of events 1 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/57 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/53 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/54 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
|
General disorders
Hematoma
|
1.3%
3/234 • Number of events 3 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/57 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/53 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/54 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
|
Nervous system disorders
Vasovagal reaction
|
1.7%
4/234 • Number of events 4 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
1.8%
1/57 • Number of events 1 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
1.9%
1/53 • Number of events 1 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/54 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
|
General disorders
Vomiting
|
0.85%
2/234 • Number of events 2 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/57 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/53 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/54 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
|
General disorders
Lightheadedness
|
0.00%
0/234 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/57 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
1.9%
1/53 • Number of events 1 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/54 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
|
General disorders
Migraine
|
0.43%
1/234 • Number of events 1 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/57 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/53 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/54 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
|
Musculoskeletal and connective tissue disorders
Bone fracture
|
0.43%
1/234 • Number of events 1 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/57 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
1.9%
1/53 • Number of events 1 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/54 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
|
Vascular disorders
High blood pressure
|
0.43%
1/234 • Number of events 1 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/57 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/53 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/54 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
|
Musculoskeletal and connective tissue disorders
Ankle sprain
|
0.43%
1/234 • Number of events 1 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/57 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/53 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/54 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
|
Surgical and medical procedures
Tested to rule out meningitis
|
0.43%
1/234 • Number of events 1 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/57 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/53 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/54 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
|
Metabolism and nutrition disorders
Possible post-viral lactose intolerance
|
0.43%
1/234 • Number of events 1 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/57 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/53 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/54 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
|
General disorders
Food intolerance
|
0.43%
1/234 • Number of events 1 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/57 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/53 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/54 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
|
General disorders
Hypertension (new prescription medication)
|
0.43%
1/234 • Number of events 1 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/57 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/53 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/54 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.43%
1/234 • Number of events 1 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/57 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/53 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/54 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/234 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
3.5%
2/57 • Number of events 2 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/53 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/54 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
|
Infections and infestations
Pericarditis
|
0.00%
0/234 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/57 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
1.9%
1/53 • Number of events 1 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
0.00%
0/54 • Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
|
Additional Information
Cara Ebbeling, PhD, Co-Director, New Balance Foundation Obesity Prevention Center
Boston Children's Hospital
Phone: 617-919-3457
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place