Trial Outcomes & Findings for Dietary Approaches to Stop Hypertension for Diabetes (NCT NCT04286555)
NCT ID: NCT04286555
Last Updated: 2026-05-13
Results Overview
After the participant has rested quietly in the seated position for at least 5 minutes, blood pressure will be measured in triplicate, using an Omron device, with each reading separated by 30 seconds, and the average of the three readings (in mmHg) will also be recorded. Blood pressure will be measured on five separate occasions during the last 2 weeks of the feeding period, and the mean systolic blood pressure from these five blood pressures (15 total readings) will be used as the primary outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
105 participants
Primary outcome timeframe
At the end of 5-week feeding period
Results posted on
2026-05-13
Participant Flow
The DASH4D trial recruited participants from June 2021 to December 2023, primarily through mass mailings of brochures, letters to prior participants, newspaper ads, and word of mouth. Prior to enrollment, participants completed a prescreening telephone interview, 3 in-person screening visits, and a run-in period to determine eligibility for the trial prior to randomization. The study was conducted at a single-site community-based research center.
105 participants were randomized to 1 of 24 possible sequences of the 4 study diets in random order (i.e., within-subjects crossover). However, 2 participants never started any study diets and 1 started the first diet but withdrew before any outcome assessments and were excluded from the analytic population (n=102). All participants were invited to the concurrent CGM Ancillary Study, but 3 did not consent, 8 changed their mind before outcome assessment, and 2 had contraindications (CGM n=89).
Participant milestones
| Measure |
DASH4D Trial Analytic Population
Participants were randomized to one of 24 possible sequences of the four study diets, in random order, in this within-subjects crossover trial. The four diets were:
1. DASH4D diet with lower sodium (DL diet)
2. DASH4D diet with higher sodium (DH diet)
3. Comparison diet with lower sodium (CL diet)
4. Comparison diet with higher sodium (CH diet)
The DASH4D diet is a DASH-style dietary pattern, modified for people with diabetes. DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH diet lowers blood pressure. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrates.
The comparison diet is a dietary pattern that is typical of what many Americans with diabetes eat. It is based on macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
Lower sodium level: 1500 mg/day (at the 2000 kilocalorie level).
Higher sodium level: 3700 mg/day (at the 2000 kilocalorie level).
|
|---|---|
|
First Feeding Period (5 Weeks)
STARTED
|
102
|
|
First Feeding Period (5 Weeks)
DASH4D Diet With Lower Sodium (DL)
|
23
|
|
First Feeding Period (5 Weeks)
DASH4D Diet With Higher Sodium (DH)
|
27
|
|
First Feeding Period (5 Weeks)
Comparison Diet With Lower Sodium (CL)
|
25
|
|
First Feeding Period (5 Weeks)
Comparison Diet With Higher Sodium (CH)
|
27
|
|
First Feeding Period (5 Weeks)
Participated in CGM Assessment During First Feeding Period
|
86
|
|
First Feeding Period (5 Weeks)
COMPLETED
|
101
|
|
First Feeding Period (5 Weeks)
NOT COMPLETED
|
1
|
|
Break 1 (at Least 1 Week)
STARTED
|
101
|
|
Break 1 (at Least 1 Week)
COMPLETED
|
98
|
|
Break 1 (at Least 1 Week)
NOT COMPLETED
|
3
|
|
Second Feeding Period (5 Weeks)
STARTED
|
98
|
|
Second Feeding Period (5 Weeks)
DASH4D Diet With Lower Sodium
|
26
|
|
Second Feeding Period (5 Weeks)
DASH4D Diet With Higher Sodium
|
23
|
|
Second Feeding Period (5 Weeks)
Comparison Diet With Lower Sodium
|
24
|
|
Second Feeding Period (5 Weeks)
Comparison Diet With Higher Sodium
|
25
|
|
Second Feeding Period (5 Weeks)
Participated in CGM Assessment During Second Feeding Period
|
80
|
|
Second Feeding Period (5 Weeks)
COMPLETED
|
97
|
|
Second Feeding Period (5 Weeks)
NOT COMPLETED
|
1
|
|
Break 2 (at Least 1 Week)
STARTED
|
97
|
|
Break 2 (at Least 1 Week)
COMPLETED
|
90
|
|
Break 2 (at Least 1 Week)
NOT COMPLETED
|
7
|
|
Third Feeding Period (5 Weeks)
STARTED
|
90
|
|
Third Feeding Period (5 Weeks)
DASH4D Diet With Lower Sodium
|
22
|
|
Third Feeding Period (5 Weeks)
DASH4D Diet With Higher Sodium
|
22
|
|
Third Feeding Period (5 Weeks)
Comparison Diet With Lower Sodium
|
24
|
|
Third Feeding Period (5 Weeks)
Comparison Diet With Higher Sodium
|
22
|
|
Third Feeding Period (5 Weeks)
Participated in CGM Assessment During Third Feeding Period
|
69
|
|
Third Feeding Period (5 Weeks)
COMPLETED
|
88
|
|
Third Feeding Period (5 Weeks)
NOT COMPLETED
|
2
|
|
Break 3 (at Least 1 Week)
STARTED
|
88
|
|
Break 3 (at Least 1 Week)
COMPLETED
|
87
|
|
Break 3 (at Least 1 Week)
NOT COMPLETED
|
1
|
|
Feeding Period 4 (5 Weeks)
STARTED
|
87
|
|
Feeding Period 4 (5 Weeks)
DASH4D Diet With Lower Sodium
|
21
|
|
Feeding Period 4 (5 Weeks)
DASH4D Diet With Higher Sodium
|
21
|
|
Feeding Period 4 (5 Weeks)
Comparison Diet With Lower Sodium
|
22
|
|
Feeding Period 4 (5 Weeks)
Comparison Diet With Higher Sodium
|
23
|
|
Feeding Period 4 (5 Weeks)
Participated in CGM Assessment During Fourth Feeding Period
|
66
|
|
Feeding Period 4 (5 Weeks)
COMPLETED
|
85
|
|
Feeding Period 4 (5 Weeks)
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
DASH4D Trial Analytic Population
Participants were randomized to one of 24 possible sequences of the four study diets, in random order, in this within-subjects crossover trial. The four diets were:
1. DASH4D diet with lower sodium (DL diet)
2. DASH4D diet with higher sodium (DH diet)
3. Comparison diet with lower sodium (CL diet)
4. Comparison diet with higher sodium (CH diet)
The DASH4D diet is a DASH-style dietary pattern, modified for people with diabetes. DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH diet lowers blood pressure. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrates.
The comparison diet is a dietary pattern that is typical of what many Americans with diabetes eat. It is based on macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
Lower sodium level: 1500 mg/day (at the 2000 kilocalorie level).
Higher sodium level: 3700 mg/day (at the 2000 kilocalorie level).
|
|---|---|
|
First Feeding Period (5 Weeks)
1 participant on the CL diet did not complete the first feeding period.
|
1
|
Baseline Characteristics
Dietary Approaches to Stop Hypertension for Diabetes
Baseline characteristics by cohort
| Measure |
DASH4D All Participants
n=102 Participants
All participants who were randomized and analyzed.
|
|---|---|
|
Age, Continuous
|
66.0 years
STANDARD_DEVIATION 8.8 • n=1512 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=1512 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=1512 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=1512 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
100 Participants
n=1512 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Black or African American
|
89 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
PRIMARY outcome
Timeframe: At the end of 5-week feeding periodPopulation: The analysis population reflects the number of participants who started the diet and completed at least one of the five blood pressure assessments during the last 2 weeks of the feeding period.
After the participant has rested quietly in the seated position for at least 5 minutes, blood pressure will be measured in triplicate, using an Omron device, with each reading separated by 30 seconds, and the average of the three readings (in mmHg) will also be recorded. Blood pressure will be measured on five separate occasions during the last 2 weeks of the feeding period, and the mean systolic blood pressure from these five blood pressures (15 total readings) will be used as the primary outcome.
Outcome measures
| Measure |
DASH4D Diet With Lower Sodium
n=89 Participants
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 1500 mg/day
DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level)
|
DASH4D Diet With Higher Sodium
n=92 Participants
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 3700 mg/day
DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level)
|
Comparison Diet With Lower Sodium
n=95 Participants
Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 1500 mg/day
comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level)
|
Comparison Diet With Higher Sodium
n=97 Participants
Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 3700 mg/day
comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level)
|
|---|---|---|---|---|
|
Systolic Blood Pressure (SBP)
|
122.4 mmHg
Standard Deviation 13.3
|
127.2 mmHg
Standard Deviation 13.7
|
124.8 mmHg
Standard Deviation 15.2
|
127.0 mmHg
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: At the end of 5-week feeding periodPopulation: The analysis population reflects the number of participants who started the diet and completed at least one of the five blood pressure assessments during the last 2 weeks of the feeding period.
After the participant has rested quietly in the seated position for at least 5 minutes, blood pressure will be measured in triplicate, using an Omron device, with each reading separated by 30 seconds, and the average of the three readings (in mmHg) will also be recorded. Blood pressure will be measured on five separate occasions during the last 2 weeks of the feeding period, and the mean diastolic blood pressure from these five blood pressures (15 total readings) will be used as a secondary outcome.
Outcome measures
| Measure |
DASH4D Diet With Lower Sodium
n=89 Participants
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 1500 mg/day
DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level)
|
DASH4D Diet With Higher Sodium
n=92 Participants
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 3700 mg/day
DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level)
|
Comparison Diet With Lower Sodium
n=95 Participants
Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 1500 mg/day
comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level)
|
Comparison Diet With Higher Sodium
n=97 Participants
Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 3700 mg/day
comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level)
|
|---|---|---|---|---|
|
Diastolic Blood Pressure (DBP)
|
67.4 mmHg
Standard Deviation 10.0
|
69.9 mmHg
Standard Deviation 10.0
|
68.8 mmHg
Standard Deviation 11.2
|
69.4 mmHg
Standard Deviation 9.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodGlycated albumin percentage (%).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodFructosamine level in mmol/L.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodFasting glucose level in mg/dL.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodHbA1c percentage (%).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodCurrent 10-year atherosclerotic cardiovascular disease (ASCVD) risk will be reported as a percent, using the American College of Cardiology (ACC)/American Heart Association (AHA) ASCVD risk equation.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodTotal cholesterol level in mg/dL.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodLDL cholesterol level in mg/dL.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodHDL cholesterol level in mg/dL.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodTriglyceride level in mg/dL.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodParticipants will lie in the supine position for 5 minutes and undergo three blood pressure measurements, separated by 30 seconds. The average of these three readings will be used as the supine blood pressure. Participants will stand with their arm rested on an adjacent Mayo table at 70-80 degrees from their torso, and participants will then undergo another set of triplicate blood pressure measurements, separated by 30 seconds each. The average of these three readings will be used as the standing blood pressure. Presence of orthostatic hypotension will be defined as ≥ 20 mmHg drop in systolic blood pressure or a ≥ 10 mmHg drop in diastolic blood pressure upon standing.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodParticipants will lie in the supine position for 5 minutes and undergo three blood pressure measurements, separated by 30 seconds. The average of these three readings will be used as the supine blood pressure. Participants will stand with their arm rested on an adjacent Mayo table at 70-80 degrees from their torso, and participants will then undergo another set of triplicate blood pressure measurements, separated by 30 seconds each. The average of these three readings will be used as the standing blood pressure. Change in systolic blood pressure (mmHg) upon standing will be calculated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodParticipants will lie in the supine position for 5 minutes and undergo three blood pressure measurements, separated by 30 seconds. The average of these three readings will be used as the supine blood pressure. Participants will stand with their arm rested on an adjacent Mayo table at 70-80 degrees from their torso, and participants will then undergo another set of triplicate blood pressure measurements, separated by 30 seconds each. The average of these three readings will be used as the standing blood pressure. Change in diastolic blood pressure (mmHg) upon standing will be calculated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodParticipants will complete a questionnaire about symptoms experienced while on each diet, including symptoms related to fall risk (e.g., feeling faint), food intake and output (e.g., bloating, constipation), fluid intake and output (e.g., excessive thirst), and general symptoms (e.g., fatigue or low energy). Participants will be asked to rate each listed symptom as: did not occur, mild, moderate, or severe. Score range 0-69, higher score worse symptoms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 14-day wear period during weeks 3-5Population: The analysis population for the CGM ancillary study outcomes was the 89 participants from the main trial's analytic population who completed at least one CGM outcome assessment wear period.
CGM Ancillary Study Primary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The mean of these glucose measurements (in mg/dL) during the 14-day wear period will be used as a primary outcome of the corresponding feeding period.
Outcome measures
| Measure |
DASH4D Diet With Lower Sodium
n=89 Participants
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 1500 mg/day
DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level)
|
DASH4D Diet With Higher Sodium
n=89 Participants
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 3700 mg/day
DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level)
|
Comparison Diet With Lower Sodium
Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 1500 mg/day
comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level)
|
Comparison Diet With Higher Sodium
Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 3700 mg/day
comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level)
|
|---|---|---|---|---|
|
Mean Continuous Glucose Monitoring Sensor Glucose
|
132.4 mg/dL
Interval 125.0 to 139.9
|
143.5 mg/dL
Interval 136.2 to 150.8
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodPopulation: The analysis population for the CGM ancillary study outcomes was the 89 participants from the main trial's analytic population who completed at least one CGM outcome assessment wear period.
CGM Ancillary Study Primary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was between 70 and 180 mg/dL (time-in-range) during 14-day wear period will be used as a primary outcome of the corresponding feeding period.
Outcome measures
| Measure |
DASH4D Diet With Lower Sodium
n=89 Participants
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 1500 mg/day
DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level)
|
DASH4D Diet With Higher Sodium
n=89 Participants
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 3700 mg/day
DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level)
|
Comparison Diet With Lower Sodium
Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 1500 mg/day
comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level)
|
Comparison Diet With Higher Sodium
Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 3700 mg/day
comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level)
|
|---|---|---|---|---|
|
Percentage of Time Glucose Between 70 and 180 mg/dL
|
83.0 % time in range
Interval 79.0 to 87.1
|
77.8 % time in range
Interval 73.8 to 81.8
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodPopulation: The analysis population for the CGM ancillary study outcomes was the 89 participants from the main trial's analytic population who completed at least one CGM outcome assessment wear period.
CGM Ancillary Study Primary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The glucose coefficient of variation (standard deviation divided by mean glucose, multiplied by 100 and expressed as a percent) during the 14-day wear period will be used as a primary outcome of the corresponding feeding period.
Outcome measures
| Measure |
DASH4D Diet With Lower Sodium
n=89 Participants
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 1500 mg/day
DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level)
|
DASH4D Diet With Higher Sodium
n=89 Participants
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 3700 mg/day
DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level)
|
Comparison Diet With Lower Sodium
Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 1500 mg/day
comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level)
|
Comparison Diet With Higher Sodium
Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 3700 mg/day
comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level)
|
|---|---|---|---|---|
|
Glucose Coefficient of Variation (%)
|
25.8 % coefficient of variation
Interval 24.5 to 27.0
|
26.1 % coefficient of variation
Interval 24.8 to 27.3
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodPopulation: The analysis population for the CGM ancillary study outcomes was the 89 participants from the main trial's analytic population who completed at least one CGM outcome assessment wear period.
CGM Ancillary Study Secondary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The standard deviation of glucose measurements (in mg/dL) will be used as a secondary outcome of the corresponding feeding period.
Outcome measures
| Measure |
DASH4D Diet With Lower Sodium
n=89 Participants
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 1500 mg/day
DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level)
|
DASH4D Diet With Higher Sodium
n=89 Participants
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 3700 mg/day
DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level)
|
Comparison Diet With Lower Sodium
Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 1500 mg/day
comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level)
|
Comparison Diet With Higher Sodium
Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 3700 mg/day
comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level)
|
|---|---|---|---|---|
|
Glucose Standard Deviation
|
34.2 mg/dL
Interval 31.6 to 36.8
|
37.5 mg/dL
Interval 34.9 to 40.1
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodPopulation: The analysis population for the CGM ancillary study outcomes was the 89 participants from the main trial's analytic population who completed at least one CGM outcome assessment wear period.
CGM Ancillary Study Secondary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was above 180 mg/dL during the 14-day wear period will be used as a secondary outcome of the corresponding feeding period.
Outcome measures
| Measure |
DASH4D Diet With Lower Sodium
n=89 Participants
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 1500 mg/day
DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level)
|
DASH4D Diet With Higher Sodium
n=89 Participants
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 3700 mg/day
DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level)
|
Comparison Diet With Lower Sodium
Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 1500 mg/day
comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level)
|
Comparison Diet With Higher Sodium
Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 3700 mg/day
comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level)
|
|---|---|---|---|---|
|
Percentage of Time Glucose Above 180 mg/dL
|
14.0 % time above 180 mg/dL
Interval 9.9 to 18.1
|
19.9 % time above 180 mg/dL
Interval 15.8 to 23.9
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodPopulation: The analysis population for the CGM ancillary study outcomes was the 89 participants from the main trial's analytic population who completed at least one CGM outcome assessment wear period.
CGM Ancillary Study Secondary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was above 250 mg/dL during the 14-day wear period will be used as a secondary outcome of the corresponding feeding period.
Outcome measures
| Measure |
DASH4D Diet With Lower Sodium
n=89 Participants
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 1500 mg/day
DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level)
|
DASH4D Diet With Higher Sodium
n=89 Participants
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 3700 mg/day
DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level)
|
Comparison Diet With Lower Sodium
Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 1500 mg/day
comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level)
|
Comparison Diet With Higher Sodium
Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 3700 mg/day
comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level)
|
|---|---|---|---|---|
|
Percentage of Time Glucose Above 250 mg/dL
|
2.9 % time above 250 mg/dL
Interval 0.5 to 5.3
|
5.6 % time above 250 mg/dL
Interval 3.3 to 8.0
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodPopulation: The analysis population for the CGM ancillary study outcomes was the 89 participants from the main trial's analytic population who completed at least one CGM outcome assessment wear period.
CGM Ancillary Study Secondary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was below 70 mg/dL during the 14-day wear period will be used as a secondary outcome of the corresponding feeding period.
Outcome measures
| Measure |
DASH4D Diet With Lower Sodium
n=89 Participants
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 1500 mg/day
DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level)
|
DASH4D Diet With Higher Sodium
n=89 Participants
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 3700 mg/day
DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level)
|
Comparison Diet With Lower Sodium
Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 1500 mg/day
comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level)
|
Comparison Diet With Higher Sodium
Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 3700 mg/day
comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level)
|
|---|---|---|---|---|
|
Percentage of Time Glucose Below 70 mg/dL
|
3.1 % time below 70 mg/dL
Interval 2.1 to 4.0
|
2.4 % time below 70 mg/dL
Interval 1.4 to 3.3
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodPopulation: The analysis population for the CGM ancillary study outcomes was the 89 participants from the main trial's analytic population who completed at least one CGM outcome assessment wear period.
CGM Ancillary Study Secondary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was below 54 mg/dL during the 14-day wear period will be used as a secondary outcome of the corresponding feeding period.
Outcome measures
| Measure |
DASH4D Diet With Lower Sodium
n=89 Participants
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 1500 mg/day
DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level)
|
DASH4D Diet With Higher Sodium
n=89 Participants
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 3700 mg/day
DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level)
|
Comparison Diet With Lower Sodium
Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 1500 mg/day
comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level)
|
Comparison Diet With Higher Sodium
Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 3700 mg/day
comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level)
|
|---|---|---|---|---|
|
Percentage of Time Glucose Below 54 mg/dL
|
0.8 % time below 54 mg/dL
Interval 0.3 to 1.2
|
0.6 % time below 54 mg/dL
Interval 0.2 to 1.0
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodCGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was between 70 and 140 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodCGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was above 140 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodCGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The proportion of participants that spent \>70% of time with glucose between 70 and 180 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodCGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The proportion of participants with a glucose coefficient of variation \<36% during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodCGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The proportion of participants that spent \<25% of time with glucose above 180 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodCGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The proportion of participants that spent \<5% of time with glucose above 250 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodCGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The proportion of participants that spent \<4% of time with glucose below 70 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of 5-week feeding periodCGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The proportion of participants that spent \<1% of time with glucose below 54 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period.
Outcome measures
Outcome data not reported
Adverse Events
DASH4D Diet With Lower Sodium
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
DASH4D Diet With Higher Sodium
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Comparison Diet With Lower Sodium
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Comparison Diet With Higher Sodium
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
CGM Ancillary Study
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DASH4D Diet With Lower Sodium
n=92 participants at risk
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 1500 mg/day
DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level)
|
DASH4D Diet With Higher Sodium
n=93 participants at risk
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 3700 mg/day
DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level)
|
Comparison Diet With Lower Sodium
n=95 participants at risk
Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 1500 mg/day
comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level)
|
Comparison Diet With Higher Sodium
n=97 participants at risk
Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 3700 mg/day
comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level)
|
CGM Ancillary Study
n=89 participants at risk
Participants were offered continuous glucose monitoring (CGM). A novel systems technology recommended for assessing real-time glucose patterns, biochemical hypoglycemia, and glycemic variability.
|
|---|---|---|---|---|---|
|
Cardiac disorders
myocardial infarction
|
1.1%
1/92 • Number of events 1 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
0.00%
0/93 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
0.00%
0/95 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
0.00%
0/97 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
0.00%
0/89 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
|
Cardiac disorders
decompensated heart failure
|
0.00%
0/92 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
0.00%
0/93 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
1.1%
1/95 • Number of events 1 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
0.00%
0/97 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
0.00%
0/89 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
Other adverse events
| Measure |
DASH4D Diet With Lower Sodium
n=92 participants at risk
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 1500 mg/day
DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level)
|
DASH4D Diet With Higher Sodium
n=93 participants at risk
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 3700 mg/day
DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level)
|
Comparison Diet With Lower Sodium
n=95 participants at risk
Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 1500 mg/day
comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level)
|
Comparison Diet With Higher Sodium
n=97 participants at risk
Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 3700 mg/day
comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level)
|
CGM Ancillary Study
n=89 participants at risk
Participants were offered continuous glucose monitoring (CGM). A novel systems technology recommended for assessing real-time glucose patterns, biochemical hypoglycemia, and glycemic variability.
|
|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
hyperkalemia
|
2.2%
2/92 • Number of events 2 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
0.00%
0/93 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
1.1%
1/95 • Number of events 1 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
0.00%
0/97 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
0.00%
0/89 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
|
Cardiac disorders
hypertension escape level 2
|
0.00%
0/92 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
0.00%
0/93 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
3.2%
3/95 • Number of events 3 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
3.1%
3/97 • Number of events 3 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
0.00%
0/89 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
|
Cardiac disorders
hypotension
|
5.4%
5/92 • Number of events 6 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
1.1%
1/93 • Number of events 1 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
6.3%
6/95 • Number of events 11 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
2.1%
2/97 • Number of events 2 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
0.00%
0/89 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
|
Endocrine disorders
hypoglycemia
|
2.2%
2/92 • Number of events 2 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
5.4%
5/93 • Number of events 13 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
4.2%
4/95 • Number of events 6 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
3.1%
3/97 • Number of events 5 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
0.00%
0/89 • From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff. To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place