Trial Outcomes & Findings for Prolonged Daily Fasting as a Viable Alternative to Caloric Restriction in At-Risk Obese Humans (NCT NCT04259632)
NCT ID: NCT04259632
Last Updated: 2025-12-30
Results Overview
Weight will be measured by standard scale and reported in kilograms. This between 2 time points - baseline and 12 weeks
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
115 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-12-30
Participant Flow
Participant milestones
| Measure |
Time Restricted Eating (TRE)
For the TRE group, we will restrict the eating window to 8 hours, where they will eat ad libitum. This is the same interval established by Dr. Panda and by our preliminary data. This interval will be entered into the mCC app and participants will be asked to adhere to this eating window during the intervention. All eating occasions will be logged using the mCC app. Only water and medications will be allowed outside of the eating window.
Time Restricted Eating (TRE): daily eating window restricted to 8 hours
|
Caloric Restriction (CR)
Participants randomized to CR will meet with the study dietitian prior to the intervention and be counseled on options to reduce their caloric intake by 15%, while maintaining their eating window. The 15% reduction was selected as our preliminary data and recent literature suggest that TRE with ad libitum intake reduces caloric intake by \~270 to 300 cal/day. The 15% CR is similar to the 11.9% CR achieved by the CALERIE-2 study, which is a 2 year study of CR.26 All eating occasions will be logged using the mCC app. The weekly dietitian review of the mCC information will include maintenance of the eating window and examination of dietary intake to determine compliance with the 15% CR.
Caloric Restriction (CR): 15% daily caloric deficient
|
Unrestricted Eating (Non-TRE)
For the unrestricted eating (non-TRE) group, participants will eat ad libitum per their usual habits. They will receive initial counseling about mCC logging. All eating occasions will be logged using the mCC app.
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
29
|
|
Overall Study
COMPLETED
|
29
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prolonged Daily Fasting as a Viable Alternative to Caloric Restriction in At-Risk Obese Humans
Baseline characteristics by cohort
| Measure |
Time Restricted Eating (TRE)
n=30 Participants
For the TRE group, we will restrict the eating window to 8 hours, where they will eat ad libitum. This is the same interval established by Dr. Panda and by our preliminary data. This interval will be entered into the mCC app and participants will be asked to adhere to this eating window during the intervention. All eating occasions will be logged using the mCC app. Only water and medications will be allowed outside of the eating window.
Time Restricted Eating (TRE): daily eating window restricted to 8 hours
|
Caloric Restriction (CR)
n=29 Participants
Participants randomized to CR will meet with the study dietitian prior to the intervention and be counseled on options to reduce their caloric intake by 15%, while maintaining their eating window. The 15% reduction was selected as our preliminary data and recent literature suggest that TRE with ad libitum intake reduces caloric intake by \~270 to 300 cal/day. The 15% CR is similar to the 11.9% CR achieved by the CALERIE-2 study, which is a 2 year study of CR.26 All eating occasions will be logged using the mCC app. The weekly dietitian review of the mCC information will include maintenance of the eating window and examination of dietary intake to determine compliance with the 15% CR.
Caloric Restriction (CR): 15% daily caloric deficient
|
Unrestricted Eating (Non-TRE)
n=29 Participants
For the unrestricted eating (non-TRE) group, participants will eat ad libitum per their usual habits. They will receive initial counseling about mCC logging. All eating occasions will be logged using the mCC app.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=174 Participants
|
29 Participants
n=166 Participants
|
29 Participants
n=167 Participants
|
88 Participants
n=164 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=174 Participants
|
15 Participants
n=166 Participants
|
16 Participants
n=167 Participants
|
48 Participants
n=164 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=174 Participants
|
14 Participants
n=166 Participants
|
13 Participants
n=167 Participants
|
40 Participants
n=164 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=174 Participants
|
1 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
1 Participants
n=164 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=174 Participants
|
2 Participants
n=166 Participants
|
3 Participants
n=167 Participants
|
7 Participants
n=164 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
1 Participants
n=164 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
1 Participants
n=167 Participants
|
3 Participants
n=164 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=174 Participants
|
26 Participants
n=166 Participants
|
25 Participants
n=167 Participants
|
74 Participants
n=164 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
2 Participants
n=164 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
PRIMARY outcome
Timeframe: 12 weeksWeight will be measured by standard scale and reported in kilograms. This between 2 time points - baseline and 12 weeks
Outcome measures
| Measure |
Time Restricted Eating (TRE)
n=29 Participants
For the TRE group, we will restrict the eating window to 8 hours, where they will eat ad libitum. This is the same interval established by Dr. Panda and by our preliminary data. This interval will be entered into the mCC app and participants will be asked to adhere to this eating window during the intervention. All eating occasions will be logged using the mCC app. Only water and medications will be allowed outside of the eating window.
Time Restricted Eating (TRE): daily eating window restricted to 8 hours
|
Caloric Restriction (CR)
n=26 Participants
Participants randomized to CR will meet with the study dietitian prior to the intervention and be counseled on options to reduce their caloric intake by 15%, while maintaining their eating window. The 15% reduction was selected as our preliminary data and recent literature suggest that TRE with ad libitum intake reduces caloric intake by \~270 to 300 cal/day. The 15% CR is similar to the 11.9% CR achieved by the CALERIE-2 study, which is a 2 year study of CR.26 All eating occasions will be logged using the mCC app. The weekly dietitian review of the mCC information will include maintenance of the eating window and examination of dietary intake to determine compliance with the 15% CR.
Caloric Restriction (CR): 15% daily caloric deficient
|
Unrestricted Eating (Non-TRE)
n=26 Participants
For the unrestricted eating (non-TRE) group, participants will eat ad libitum per their usual habits. They will receive initial counseling about mCC logging. All eating occasions will be logged using the mCC app.
|
|---|---|---|---|
|
Change in Weight
|
-3 Kg
Interval -4.1 to -1.9
|
-3.5 Kg
Interval -4.7 to -2.3
|
-1.3 Kg
Interval -2.5 to -0.1
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksBody composition will be measured by dual energy x-ray absorptometry (DXA). Parameters of body composition will be calculated by integrated DXA software. Whole body percent fat will be reported as a percentage.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeksBody composition will be measured by dual energy x-ray absorptometry (DXA). Parameters of body composition will be calculated by integrated DXA software. Visceral fat will be reported in grams.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeksBody composition will be measured by dual energy x-ray absorptometry (DXA). Parameters of body composition will be calculated by integrated DXA software. Lean mass will be reported in kilograms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeksBody composition will be measured by dual energy x-ray absorptometry (DXA). Parameters of body composition will be calculated by integrated DXA software. Fat mass will be reported in kilograms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeksTwo interviewer-administered 24-hour dietary recalls will be collected from each participant at baseline and 12 weeks. The recalls will be conducted over the telephone and will be unannounced to minimize measurement reactivity. Diet data will be collected using the Nutrition Data System for Research (NDSR) to calculate Calories. Calories will be averaged across the 2 recalls at each time point. Outcome will be reported as difference between average caloric intake at baseline and 12 weeks. Outcome will be reported in kilocalories (Calories).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 12 weeksindirect calorimetry to measure glucose and fat oxidation for \~ 30 minutes before and at the end of the 2 step 4-hour hyperinsulinemic-euglycemic clamp \[low-dose (10 mU/m2/min) insulin infusion for 2 hours, high-dose (40 mU/m2/min) insulin infusion for 2 hours\] Fluctuations in VO2 and VCO2 in the first 5-10 minutes of data acquisition were removed and the mean VO2 and VCO2 at steady state was used for data analysis. The respiratory exchange ratio (RER) was calculated by VCO2 / VO2. . Metabolic flexibility was calculated by the RERclamp-RERrest
Outcome measures
Outcome data not reported
Adverse Events
Time Restricted Eating (TRE)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Caloric Restriction (CR)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Unrestricted Eating (Non-TRE)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Time Restricted Eating (TRE)
n=30 participants at risk
For the TRE group, we will restrict the eating window to 8 hours, where they will eat ad libitum. This is the same interval established by Dr. Panda and by our preliminary data. This interval will be entered into the mCC app and participants will be asked to adhere to this eating window during the intervention. All eating occasions will be logged using the mCC app. Only water and medications will be allowed outside of the eating window.
Time Restricted Eating (TRE): daily eating window restricted to 8 hours
|
Caloric Restriction (CR)
n=29 participants at risk
Participants randomized to CR will meet with the study dietitian prior to the intervention and be counseled on options to reduce their caloric intake by 15%, while maintaining their eating window. The 15% reduction was selected as our preliminary data and recent literature suggest that TRE with ad libitum intake reduces caloric intake by \~270 to 300 cal/day. The 15% CR is similar to the 11.9% CR achieved by the CALERIE-2 study, which is a 2 year study of CR.26 All eating occasions will be logged using the mCC app. The weekly dietitian review of the mCC information will include maintenance of the eating window and examination of dietary intake to determine compliance with the 15% CR.
Caloric Restriction (CR): 15% daily caloric deficient
|
Unrestricted Eating (Non-TRE)
n=29 participants at risk
For the unrestricted eating (non-TRE) group, participants will eat ad libitum per their usual habits. They will receive initial counseling about mCC logging. All eating occasions will be logged using the mCC app.
|
|---|---|---|---|
|
General disorders
ER evaluation for kidney stones and diverticulosis
|
0.00%
0/30 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
3.4%
1/29 • Number of events 1 • 12 weeks
|
|
General disorders
Chest pain
|
0.00%
0/30 • 12 weeks
|
3.4%
1/29 • Number of events 1 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
|
General disorders
ER eval for TIA
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place