Trial Outcomes & Findings for Effect of Time-restricted Eating on Catecholamine-sensitivity of Adipose Tissue in Obese Adults (NCT NCT04916730)
NCT ID: NCT04916730
Last Updated: 2025-10-14
Results Overview
Measured as change in weight (kg).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
61 participants
Primary outcome timeframe
Baseline to end of 12 week intervention
Results posted on
2025-10-14
Participant Flow
Participants were recruited based on physician referral at a single academic center between November 2020 and February 2023. The first potential participant screened for study eligibility was on December 3, 2020 (enrolled (randomized) December 17, 2020) and the last participant screened for eligibility was in February 2023.
Out of 85 potential participants screened for study eligibility, 61 met the inclusion criteria and were subsequently randomized to treatment. One participant was excluded from analysis because of an underlying muscular dystrophy known to affect body composition.
Participant milestones
| Measure |
Standard of Care (SOC)
Participants will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.
Standard of Care: Participants in this arm will receive nutritional counseling from the study dietician but will not be required to adopt a 10-hr eating window.
|
TRE + SOC
Participants in this arm will receive standard of care nutritional behavioral counseling and will implement a daily, self-selected, 10-hour window within which they must consume all calories. They will also be required to log their caloric intake through the use of a smartphone app
Time Restricted Eating: Participants in this arm will adhere to a daily, consistent self-selected 10-hr eating window for the course of the study intervention period as well as receive nutritional counseling from the study dietitian.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
29
|
|
Overall Study
COMPLETED
|
26
|
25
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Standard of Care (SOC)
Participants will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.
Standard of Care: Participants in this arm will receive nutritional counseling from the study dietician but will not be required to adopt a 10-hr eating window.
|
TRE + SOC
Participants in this arm will receive standard of care nutritional behavioral counseling and will implement a daily, self-selected, 10-hour window within which they must consume all calories. They will also be required to log their caloric intake through the use of a smartphone app
Time Restricted Eating: Participants in this arm will adhere to a daily, consistent self-selected 10-hr eating window for the course of the study intervention period as well as receive nutritional counseling from the study dietitian.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Effect of Time-restricted Eating on Catecholamine-sensitivity of Adipose Tissue in Obese Adults
Baseline characteristics by cohort
| Measure |
Standard of Care (SOC)
n=31 Participants
Participants will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.
Standard of Care: Participants in this arm will receive nutritional counseling from the study dietician but will not be required to adopt a 10-hr eating window.
|
TRE + SOC
n=29 Participants
Participants in this arm will receive standard of care nutritional behavioral counseling and will implement a daily, self-selected, 10-hour window within which they must consume all calories. They will also be required to log their caloric intake through the use of a smartphone app
Time Restricted Eating: Participants in this arm will adhere to a daily, consistent self-selected 10-hr eating window for the course of the study intervention period as well as receive nutritional counseling from the study dietitian.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
34.7 Kg^m2
STANDARD_DEVIATION 3.5 • n=5 Participants
|
36.3 Kg^m2
STANDARD_DEVIATION 5.9 • n=7 Participants
|
35.5 Kg^m2
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
Body Weight
|
100.9 Kg
STANDARD_DEVIATION 14.7 • n=5 Participants
|
101.9 Kg
STANDARD_DEVIATION 20.8 • n=7 Participants
|
101.4 Kg
STANDARD_DEVIATION 17.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of 12 week interventionPopulation: Intent to treat population (all participants assigned to Standard of Care (SOC) or TRE + SOC).
Measured as change in weight (kg).
Outcome measures
| Measure |
Standard of Care (SOC)
n=26 Participants
Participants will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.
Standard of Care: Participants in this arm will receive nutritional counseling from the study dietician but will not be required to adopt a 10-hr eating window.
|
TRE + SOC
n=25 Participants
Participants in this arm will receive standard of care nutritional behavioral counseling and will implement a daily, self-selected, 10-hour window within which they must consume all calories. They will also be required to log their caloric intake through the use of a smartphone app
Time Restricted Eating: Participants in this arm will adhere to a daily, consistent self-selected 10-hr eating window for the course of the study intervention period as well as receive nutritional counseling from the study dietitian.
|
|---|---|---|
|
Effects of TRE on Body Weight
|
-1.68 Kg
Interval -2.59 to -0.77
|
-4.59 Kg
Interval -5.51 to -3.67
|
SECONDARY outcome
Timeframe: Baseline to end of 12 week interventionMeasured as change in percent body fat.
Outcome measures
| Measure |
Standard of Care (SOC)
n=25 Participants
Participants will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.
Standard of Care: Participants in this arm will receive nutritional counseling from the study dietician but will not be required to adopt a 10-hr eating window.
|
TRE + SOC
n=25 Participants
Participants in this arm will receive standard of care nutritional behavioral counseling and will implement a daily, self-selected, 10-hour window within which they must consume all calories. They will also be required to log their caloric intake through the use of a smartphone app
Time Restricted Eating: Participants in this arm will adhere to a daily, consistent self-selected 10-hr eating window for the course of the study intervention period as well as receive nutritional counseling from the study dietitian.
|
|---|---|---|
|
Effects of TRE on Body Composition
|
-0.8 percentage of body fat
Interval -1.82 to 0.22
|
-1.3 percentage of body fat
Interval -2.15 to -0.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to end of 12 weeksPopulation: These experiments could not be conducted as planned because of budgetary constraints.
Measured as inflammatory marker mRNA.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to end of 12 week interventionPopulation: These experiments were not technically feasible with human adipose tissue
Measured as release of free fatty acids (uM).
Outcome measures
Outcome data not reported
Adverse Events
Standard of Care (SOC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TRE + SOC
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
Michael J. Wilkinson, MD
University of California, San Diego
Phone: (858)246-2510
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place