Trial Outcomes & Findings for TRE With Physical Activity for Weight Management (NCT NCT04978376)
NCT ID: NCT04978376
Last Updated: 2024-11-18
Results Overview
Body weight assessed to the nearest 0.25 kg every week without shoes and in light clothing using a balance beam scale (HealthOMeter, Boca Raton, FL).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
Change from week 1 to week 10
Results posted on
2024-11-18
Participant Flow
Participant milestones
| Measure |
Time Restricted Eating
ad-libitum eating between 12:00-20:00
Time restricted eating: We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group.
|
TRE With Endurance Training
ad-libitum eating between 12:00-20:00 with 3-5 days of supervised endurance exercise per week
Time restricted eating: We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group.
|
TRE With Resistance Training
ad-libitum eating between 12:00-20:00 with 3-5 days of supervised resistance training per week
Time restricted eating: We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group.
|
Control
no change in diet or physical activity
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
5
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TRE With Physical Activity for Weight Management
Baseline characteristics by cohort
| Measure |
Time Restricted Eating
n=4 Participants
ad-libitum eating between 12:00-20:00
Time restricted eating: We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group.
|
TRE With Endurance Training
n=4 Participants
ad-libitum eating between 12:00-20:00 with 3-5 days of supervised endurance exercise per week
Time restricted eating: We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group.
|
TRE With Resistance Training
n=5 Participants
ad-libitum eating between 12:00-20:00 with 3-5 days of supervised resistance training per week
Time restricted eating: We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group.
|
Control
n=4 Participants
no change in diet or physical activity
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=93 Participants
|
4 participants
n=4 Participants
|
5 participants
n=27 Participants
|
4 participants
n=483 Participants
|
17 participants
n=36 Participants
|
|
BMI
|
36 kg/m^2
STANDARD_DEVIATION 4 • n=93 Participants
|
34 kg/m^2
STANDARD_DEVIATION 3 • n=4 Participants
|
36 kg/m^2
STANDARD_DEVIATION 4 • n=27 Participants
|
35 kg/m^2
STANDARD_DEVIATION 5 • n=483 Participants
|
35 kg/m^2
STANDARD_DEVIATION 4 • n=36 Participants
|
|
Weight
|
97 kilograms
STANDARD_DEVIATION 10 • n=93 Participants
|
98 kilograms
STANDARD_DEVIATION 20 • n=4 Participants
|
97 kilograms
STANDARD_DEVIATION 13 • n=27 Participants
|
89 kilograms
STANDARD_DEVIATION 16 • n=483 Participants
|
95 kilograms
STANDARD_DEVIATION 15 • n=36 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 4 • n=93 Participants
|
61 years
STANDARD_DEVIATION 6 • n=4 Participants
|
57 years
STANDARD_DEVIATION 6 • n=27 Participants
|
52 years
STANDARD_DEVIATION 5 • n=483 Participants
|
57 years
STANDARD_DEVIATION 5 • n=36 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Change from week 1 to week 10Body weight assessed to the nearest 0.25 kg every week without shoes and in light clothing using a balance beam scale (HealthOMeter, Boca Raton, FL).
Outcome measures
| Measure |
Time Restricted Eating
n=4 Participants
ad-libitum eating between 12:00-20:00
Time restricted eating: We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group.
|
TRE With Endurance Training
n=4 Participants
ad-libitum eating between 12:00-20:00 with 3-5 days of supervised endurance exercise per week
Time restricted eating: We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group.
|
TRE With Resistance Training
n=4 Participants
ad-libitum eating between 12:00-20:00 with 3-5 days of supervised resistance training per week
Time restricted eating: We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group.
|
Control
n=4 Participants
no change in diet or physical activity
|
|---|---|---|---|---|
|
Body Weight Changes Between Week 1 to Week 10
|
-2.1 Percent body weight loss
Standard Error .8
|
-4.2 Percent body weight loss
Standard Error .8
|
-1.3 Percent body weight loss
Standard Error 1.1
|
.1 Percent body weight loss
Standard Error .5
|
SECONDARY outcome
Timeframe: Change from week 1 to week 10Change in lean mass from week 1 to week 10 by DEXA
Outcome measures
| Measure |
Time Restricted Eating
n=4 Participants
ad-libitum eating between 12:00-20:00
Time restricted eating: We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group.
|
TRE With Endurance Training
n=4 Participants
ad-libitum eating between 12:00-20:00 with 3-5 days of supervised endurance exercise per week
Time restricted eating: We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group.
|
TRE With Resistance Training
n=4 Participants
ad-libitum eating between 12:00-20:00 with 3-5 days of supervised resistance training per week
Time restricted eating: We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group.
|
Control
n=4 Participants
no change in diet or physical activity
|
|---|---|---|---|---|
|
Body Composition Changes From Week 1 to Week 10
|
-3.5 percent lean mass change
Standard Error .9
|
-1.4 percent lean mass change
Standard Error .8
|
.7 percent lean mass change
Standard Error .9
|
-.3 percent lean mass change
Standard Error 5.1
|
SECONDARY outcome
Timeframe: Change from week 1 to week 10Population: t-test
insulin will be measured by enzymatic kit (uIU/ml)\^4
Outcome measures
| Measure |
Time Restricted Eating
n=4 Participants
ad-libitum eating between 12:00-20:00
Time restricted eating: We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group.
|
TRE With Endurance Training
n=4 Participants
ad-libitum eating between 12:00-20:00 with 3-5 days of supervised endurance exercise per week
Time restricted eating: We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group.
|
TRE With Resistance Training
n=5 Participants
ad-libitum eating between 12:00-20:00 with 3-5 days of supervised resistance training per week
Time restricted eating: We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group.
|
Control
n=4 Participants
no change in diet or physical activity
|
|---|---|---|---|---|
|
Change in Insulin From Week 1 to Week 10
|
-.9 (uIU/ml)^4
Standard Error .1
|
.6 (uIU/ml)^4
Standard Error .7
|
.3 (uIU/ml)^4
Standard Error 2.5
|
2 (uIU/ml)^4
Standard Error 1.3
|
SECONDARY outcome
Timeframe: Change from week 1 to week 10Population: t-test
measured by enzymatic kit (mg/dl)
Outcome measures
| Measure |
Time Restricted Eating
n=4 Participants
ad-libitum eating between 12:00-20:00
Time restricted eating: We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group.
|
TRE With Endurance Training
n=4 Participants
ad-libitum eating between 12:00-20:00 with 3-5 days of supervised endurance exercise per week
Time restricted eating: We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group.
|
TRE With Resistance Training
n=5 Participants
ad-libitum eating between 12:00-20:00 with 3-5 days of supervised resistance training per week
Time restricted eating: We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group.
|
Control
n=4 Participants
no change in diet or physical activity
|
|---|---|---|---|---|
|
Glucose
|
-.5 mg/dl
Standard Deviation 2.2
|
1.5 mg/dl
Standard Deviation 10.5
|
-5 mg/dl
Standard Deviation 1.8
|
1.7 mg/dl
Standard Deviation 8.8
|
Adverse Events
Time Restricted Eating
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TRE With Endurance Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TRE With Resistance Training
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