Trial Outcomes & Findings for Time Restricted Eating for Weight Management (NCT NCT04692532)
NCT ID: NCT04692532
Last Updated: 2026-07-27
Results Overview
Measured by an electronic scale
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
Measured at month 0 and 12
Results posted on
2026-07-27
Participant Flow
Participant milestones
| Measure |
Control
Usual diet, Ad libitum intake, eating within \>10 hours per day
|
8-hour Time Restricted Eating
Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
8-hour Time restricted eating: Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
|
Calorie Restriction
25% energy restriction every day
Calorie restriction: 25% energy restriction every day
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
26
|
26
|
25
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Time Restricted Eating for Weight Management
Baseline characteristics by cohort
| Measure |
8-hour Time Restricted Eating
n=30 Participants
Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
8-hour Time restricted eating: Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
|
Calorie Restriction
n=30 Participants
25% energy restriction every day
Calorie restriction: 25% energy restriction every day
|
Control
n=30 Participants
Usual diet, Ad libitum intake, eating within \>10 hours per day
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
17 Participants
n=267 Participants
|
41 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=9 Participants
|
19 Participants
n=27 Participants
|
13 Participants
n=267 Participants
|
49 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=9 Participants
|
30 Participants
n=27 Participants
|
30 Participants
n=267 Participants
|
90 Participants
n=265 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 12 • n=9 Participants
|
44 years
STANDARD_DEVIATION 9 • n=27 Participants
|
44 years
STANDARD_DEVIATION 13 • n=267 Participants
|
44 years
STANDARD_DEVIATION 11 • n=265 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=9 Participants
|
24 Participants
n=27 Participants
|
25 Participants
n=267 Participants
|
74 Participants
n=265 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
16 Participants
n=265 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
6 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
30 Participants
n=265 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=9 Participants
|
18 Participants
n=27 Participants
|
20 Participants
n=267 Participants
|
54 Participants
n=265 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
PRIMARY outcome
Timeframe: Measured at month 0 and 12Measured by an electronic scale
Outcome measures
| Measure |
8-hour Time Restricted Eating
n=30 Participants
Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
8-hour Time restricted eating: Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
|
Calorie Restriction
n=30 Participants
25% energy restriction every day
Calorie restriction: 25% energy restriction every day
|
Control
n=30 Participants
Usual diet, Ad libitum intake, eating within \>10 hours per day
|
|---|---|---|---|
|
Change in Body Weight
|
-3.67 percentage of body weight change
Interval -5.89 to -1.64
|
-4.20 percentage of body weight change
Interval -7.59 to -0.8
|
1.11 percentage of body weight change
Interval -0.72 to 2.94
|
SECONDARY outcome
Timeframe: Measured at month 0 and 12Measured by DXA
Outcome measures
| Measure |
8-hour Time Restricted Eating
n=30 Participants
Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
8-hour Time restricted eating: Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
|
Calorie Restriction
n=30 Participants
25% energy restriction every day
Calorie restriction: 25% energy restriction every day
|
Control
n=30 Participants
Usual diet, Ad libitum intake, eating within \>10 hours per day
|
|---|---|---|---|
|
Change in Fat Mass
|
-2.20 kg
Interval -3.88 to -0.52
|
-2.61 kg
Interval -5.97 to 0.74
|
0.57 kg
Interval -1.14 to 2.27
|
SECONDARY outcome
Timeframe: Measured at month 0 12Measured by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Values above 2.5 generally considered an indicator of insulin resistance. Higher values indicate greater insulin resistance while lower values indicate lower insulin resistance. HOMA-IR = \[glucose (mmol/L) × insulin (μU/L)\]/22.5.
Outcome measures
| Measure |
8-hour Time Restricted Eating
n=30 Participants
Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
8-hour Time restricted eating: Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
|
Calorie Restriction
n=30 Participants
25% energy restriction every day
Calorie restriction: 25% energy restriction every day
|
Control
n=30 Participants
Usual diet, Ad libitum intake, eating within \>10 hours per day
|
|---|---|---|---|
|
Change in Insulin Resistance
|
-0.49 units on a scale
Interval -1.23 to 0.24
|
0.07 units on a scale
Interval -0.47 to 0.61
|
0.54 units on a scale
Interval -0.33 to 1.41
|
SECONDARY outcome
Timeframe: Measured at month 0 and 12Measured by Quantitative Insulin Sensitivity Check Index (QUICKI). QUICKI calculated as = 1/\[log (fasting insulin, U/ml) + log (fasting glucose, mg/dl)\]. Higher scores (typically \> 0.45) indicate high insulin sensitivity. Lower scores (generally ≤ 0.33 or 0.34) indicate decreased insulin sensitivity and an increased risk for insulin resistance or type 2 diabetes.
Outcome measures
| Measure |
8-hour Time Restricted Eating
n=30 Participants
Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
8-hour Time restricted eating: Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
|
Calorie Restriction
n=30 Participants
25% energy restriction every day
Calorie restriction: 25% energy restriction every day
|
Control
n=30 Participants
Usual diet, Ad libitum intake, eating within \>10 hours per day
|
|---|---|---|---|
|
Change in Insulin Sensitivity
|
0.01 units on a scale
Interval 0.0 to 0.02
|
0 units on a scale
Interval -0.02 to 0.01
|
-0.01 units on a scale
Interval -0.02 to 0.0
|
SECONDARY outcome
Timeframe: Measured at month 0 and 12Measured by a commercial lab (Medstar, IL)
Outcome measures
| Measure |
8-hour Time Restricted Eating
n=30 Participants
Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
8-hour Time restricted eating: Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
|
Calorie Restriction
n=30 Participants
25% energy restriction every day
Calorie restriction: 25% energy restriction every day
|
Control
n=30 Participants
Usual diet, Ad libitum intake, eating within \>10 hours per day
|
|---|---|---|---|
|
Change in Fasting Glucose
|
2.82 mg/dl
Interval -1.15 to 6.79
|
5.83 mg/dl
Interval 1.25 to 10.4
|
6.26 mg/dl
Interval 1.63 to 10.9
|
SECONDARY outcome
Timeframe: Measured at month 0 and 12Measured by a commercial lab (Medstar, IL)
Outcome measures
| Measure |
8-hour Time Restricted Eating
n=30 Participants
Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
8-hour Time restricted eating: Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
|
Calorie Restriction
n=30 Participants
25% energy restriction every day
Calorie restriction: 25% energy restriction every day
|
Control
n=30 Participants
Usual diet, Ad libitum intake, eating within \>10 hours per day
|
|---|---|---|---|
|
Change in HbA1c
|
0 percentage of glycated hemoglobin
Interval -0.15 to 0.14
|
0.05 percentage of glycated hemoglobin
Interval -0.07 to 0.18
|
0.07 percentage of glycated hemoglobin
Interval -0.03 to 0.18
|
SECONDARY outcome
Timeframe: Measured at month 0 and 12Measured by a commercial lab (Medstar, IL)
Outcome measures
| Measure |
8-hour Time Restricted Eating
n=30 Participants
Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
8-hour Time restricted eating: Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
|
Calorie Restriction
n=30 Participants
25% energy restriction every day
Calorie restriction: 25% energy restriction every day
|
Control
n=30 Participants
Usual diet, Ad libitum intake, eating within \>10 hours per day
|
|---|---|---|---|
|
Change in Fasting Insulin
|
-19.65 pmol/L
Interval -37.09 to -2.29
|
-0.83 pmol/L
Interval -15.42 to 13.68
|
10 pmol/L
Interval -16.11 to 36.18
|
SECONDARY outcome
Timeframe: Measured at month 0 and 12Measured by a blood pressure cuff
Outcome measures
| Measure |
8-hour Time Restricted Eating
n=30 Participants
Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
8-hour Time restricted eating: Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
|
Calorie Restriction
n=30 Participants
25% energy restriction every day
Calorie restriction: 25% energy restriction every day
|
Control
n=30 Participants
Usual diet, Ad libitum intake, eating within \>10 hours per day
|
|---|---|---|---|
|
Change in Systolic Blood Pressure
|
-1.78 mm Hg
Interval -6.8 to 3.24
|
-4.62 mm Hg
Interval -8.92 to -0.31
|
0.06 mm Hg
Interval -4.52 to 4.64
|
SECONDARY outcome
Timeframe: Measured at month 0 and 12Measured by a blood pressure cuff
Outcome measures
| Measure |
8-hour Time Restricted Eating
n=30 Participants
Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
8-hour Time restricted eating: Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
|
Calorie Restriction
n=30 Participants
25% energy restriction every day
Calorie restriction: 25% energy restriction every day
|
Control
n=30 Participants
Usual diet, Ad libitum intake, eating within \>10 hours per day
|
|---|---|---|---|
|
Change in Diastolic Blood Pressure
|
-0.82 mm Hg
Interval -4.7 to 3.05
|
0.99 mm Hg
Interval -2.13 to 4.1
|
2.85 mm Hg
Interval 0.1 to 5.59
|
SECONDARY outcome
Timeframe: Measured at month 0 and 12Measured by a commercial lab (Medstar, IL)
Outcome measures
| Measure |
8-hour Time Restricted Eating
n=30 Participants
Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
8-hour Time restricted eating: Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
|
Calorie Restriction
n=30 Participants
25% energy restriction every day
Calorie restriction: 25% energy restriction every day
|
Control
n=30 Participants
Usual diet, Ad libitum intake, eating within \>10 hours per day
|
|---|---|---|---|
|
Change in LDL Cholesterol
|
-0.86 mg/dl
Interval -9.14 to 7.42
|
-1.33 mg/dl
Interval -7.47 to 4.81
|
2.37 mg/dl
Interval -4.51 to 9.24
|
Adverse Events
8-hour Time Restricted Eating
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Calorie Restriction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place