Trial Outcomes & Findings for Time Limited Eating in Adolescents (Time LEAd): a Pilot Study (NCT NCT03954223)
NCT ID: NCT03954223
Last Updated: 2024-03-04
Results Overview
Percent Change in BMI in excess of the 95th percentile (%BMIp95) as calculated by the CDC extended SAS equations at week 12 minus %BMIp95 at baseline. For example If the BMI is greater than the 95th percentile: BMI percentile equals 90 plus 10 times the cumulative distribution function (CDF) of the standard normal distribution. Sigma is the value from the data table corresponding to the sex of the child and the age in months. and are the cumulative distribution function (CDF) of the standard normal distribution and its inverse function. Standard normal distribution tables can be found in statistics textbooks, online sources, and statistical computer programs. Example: A boy aged 4 years and 2 months (50.5 months) with BMI = 22.6. For this boy, P95 (95th percentile) is 17.8219 so his BMI is above the 95th percentile and sigma = 2.3983.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
%BMIp95 at Week 12 minus %BMIp95 at baseline
Results posted on
2024-03-04
Participant Flow
Participant milestones
| Measure |
LSC + Blinded CGM
Group 1) Low sugar and carbohydrate diet (LSC, \<90 gm carbohydrate (CHO)/day, \<25 gm added sugar/day) + blinded CGM (used to monitor adherence and glycemic outcomes without real time feedback)
Low sugar and carbohydrate diet: Low sugar and carbohydrate diet (LSC, \<90 gm carbohydrate (CHO)/day, \<25 gm added sugar/day)
Continuous Glucose Monitor: CGM (used to monitor adherence and glycemic outcomes without real time feedback)
|
LSC+TLE + Blinded CGM
Group 2) LSC+Time limited eating (TLE) (16-hour fast/8-hour feed for 3 days per week) + blinded CGM
Low sugar and carbohydrate diet: Low sugar and carbohydrate diet (LSC, \<90 gm carbohydrate (CHO)/day, \<25 gm added sugar/day)
Time Limited Eating: 16-hour fast/8-hour feed for 3 days per week
Continuous Glucose Monitor: CGM (used to monitor adherence and glycemic outcomes without real time feedback)
|
LSC+TLE+ Real Time Feedback Via CGM
Group 3) LSC+TLE+ real time feedback via CGM (to evaluate effect of providing CGM data on intervention efficacy).
Low sugar and carbohydrate diet: Low sugar and carbohydrate diet (LSC, \<90 gm carbohydrate (CHO)/day, \<25 gm added sugar/day)
Time Limited Eating: 16-hour fast/8-hour feed for 3 days per week
Continuous Glucose Monitor: CGM (used to monitor adherence and glycemic outcomes without real time feedback)
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
19
|
16
|
|
Overall Study
COMPLETED
|
15
|
19
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Time Limited Eating in Adolescents (Time LEAd): a Pilot Study
Baseline characteristics by cohort
| Measure |
LSC + Blinded CGM
n=15 Participants
Group 1) Low sugar and carbohydrate diet (LSC, \<90 gm carbohydrate (CHO)/day, \<25 gm added sugar/day) + blinded CGM (used to monitor adherence and glycemic outcomes without real time feedback)
Low sugar and carbohydrate diet: Low sugar and carbohydrate diet (LSC, \<90 gm carbohydrate (CHO)/day, \<25 gm added sugar/day)
Continuous Glucose Monitor: CGM (used to monitor adherence and glycemic outcomes without real time feedback)
|
LSC+TLE + Blinded CGM
n=19 Participants
Group 2) LSC+Time limited eating (TLE) (16-hour fast/8-hour feed for 3 days per week) + blinded CGM
Low sugar and carbohydrate diet: Low sugar and carbohydrate diet (LSC, \<90 gm carbohydrate (CHO)/day, \<25 gm added sugar/day)
Time Limited Eating: 16-hour fast/8-hour feed for 3 days per week
Continuous Glucose Monitor: CGM (used to monitor adherence and glycemic outcomes without real time feedback)
|
LSC+TLE+ Real Time Feedback Via CGM
n=16 Participants
Group 3) LSC+TLE+ real time feedback via CGM (to evaluate effect of providing CGM data on intervention efficacy).
Low sugar and carbohydrate diet: Low sugar and carbohydrate diet (LSC, \<90 gm carbohydrate (CHO)/day, \<25 gm added sugar/day)
Time Limited Eating: 16-hour fast/8-hour feed for 3 days per week
Continuous Glucose Monitor: CGM (used to monitor adherence and glycemic outcomes without real time feedback)
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
16.38 year
STANDARD_DEVIATION 1.25 • n=5 Participants
|
16.16 year
STANDARD_DEVIATION 1.16 • n=7 Participants
|
16.80 year
STANDARD_DEVIATION 1.09 • n=5 Participants
|
16.80 year
STANDARD_DEVIATION 1.09 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
BMI Z-score
|
2.30 Z-score
STANDARD_DEVIATION 0.5 • n=5 Participants
|
2.28 Z-score
STANDARD_DEVIATION 0.4 • n=7 Participants
|
2.30 Z-score
STANDARD_DEVIATION 0.5 • n=5 Participants
|
2.30 Z-score
STANDARD_DEVIATION 0.5 • n=4 Participants
|
PRIMARY outcome
Timeframe: %BMIp95 at Week 12 minus %BMIp95 at baselinePercent Change in BMI in excess of the 95th percentile (%BMIp95) as calculated by the CDC extended SAS equations at week 12 minus %BMIp95 at baseline. For example If the BMI is greater than the 95th percentile: BMI percentile equals 90 plus 10 times the cumulative distribution function (CDF) of the standard normal distribution. Sigma is the value from the data table corresponding to the sex of the child and the age in months. and are the cumulative distribution function (CDF) of the standard normal distribution and its inverse function. Standard normal distribution tables can be found in statistics textbooks, online sources, and statistical computer programs. Example: A boy aged 4 years and 2 months (50.5 months) with BMI = 22.6. For this boy, P95 (95th percentile) is 17.8219 so his BMI is above the 95th percentile and sigma = 2.3983.
Outcome measures
| Measure |
LSC + Blinded CGM
n=15 Participants
Group 1) Low sugar and carbohydrate diet (LSC, \<90 gm carbohydrate (CHO)/day, \<25 gm added sugar/day) + blinded CGM (used to monitor adherence and glycemic outcomes without real time feedback)
Low sugar and carbohydrate diet: Low sugar and carbohydrate diet (LSC, \<90 gm carbohydrate (CHO)/day, \<25 gm added sugar/day)
Continuous Glucose Monitor: CGM (used to monitor adherence and glycemic outcomes without real time feedback)
|
LSC+TLE + Blinded CGM
n=19 Participants
Group 2) LSC+Time limited eating (TLE) (16-hour fast/8-hour feed for 3 days per week) + blinded CGM
Low sugar and carbohydrate diet: Low sugar and carbohydrate diet (LSC, \<90 gm carbohydrate (CHO)/day, \<25 gm added sugar/day)
Time Limited Eating: 16-hour fast/8-hour feed for 3 days per week
Continuous Glucose Monitor: CGM (used to monitor adherence and glycemic outcomes without real time feedback)
|
LSC+TLE+ Real Time Feedback Via CGM
n=16 Participants
Group 3) LSC+TLE+ real time feedback via CGM (to evaluate effect of providing CGM data on intervention efficacy).
Low sugar and carbohydrate diet: Low sugar and carbohydrate diet (LSC, \<90 gm carbohydrate (CHO)/day, \<25 gm added sugar/day)
Time Limited Eating: 16-hour fast/8-hour feed for 3 days per week
Continuous Glucose Monitor: CGM (used to monitor adherence and glycemic outcomes without real time feedback)
|
|---|---|---|---|
|
Percent Change in BMI in Excess of the 95th Percentile (%BMIp95)
|
-3.27 percent
Standard Deviation 3.34
|
-3.76 percent
Standard Deviation 5.76
|
-4.85 percent
Standard Deviation 5.08
|
SECONDARY outcome
Timeframe: Change in average glucose at week 12 minus average glucose at baselineAffect of TRE on change in average glucose
Outcome measures
| Measure |
LSC + Blinded CGM
n=15 Participants
Group 1) Low sugar and carbohydrate diet (LSC, \<90 gm carbohydrate (CHO)/day, \<25 gm added sugar/day) + blinded CGM (used to monitor adherence and glycemic outcomes without real time feedback)
Low sugar and carbohydrate diet: Low sugar and carbohydrate diet (LSC, \<90 gm carbohydrate (CHO)/day, \<25 gm added sugar/day)
Continuous Glucose Monitor: CGM (used to monitor adherence and glycemic outcomes without real time feedback)
|
LSC+TLE + Blinded CGM
n=19 Participants
Group 2) LSC+Time limited eating (TLE) (16-hour fast/8-hour feed for 3 days per week) + blinded CGM
Low sugar and carbohydrate diet: Low sugar and carbohydrate diet (LSC, \<90 gm carbohydrate (CHO)/day, \<25 gm added sugar/day)
Time Limited Eating: 16-hour fast/8-hour feed for 3 days per week
Continuous Glucose Monitor: CGM (used to monitor adherence and glycemic outcomes without real time feedback)
|
LSC+TLE+ Real Time Feedback Via CGM
n=16 Participants
Group 3) LSC+TLE+ real time feedback via CGM (to evaluate effect of providing CGM data on intervention efficacy).
Low sugar and carbohydrate diet: Low sugar and carbohydrate diet (LSC, \<90 gm carbohydrate (CHO)/day, \<25 gm added sugar/day)
Time Limited Eating: 16-hour fast/8-hour feed for 3 days per week
Continuous Glucose Monitor: CGM (used to monitor adherence and glycemic outcomes without real time feedback)
|
|---|---|---|---|
|
Average Glucose
|
0.5 mg/dL
Interval -20.2 to 6.0
|
-7.1 mg/dL
Interval -18.2 to 6.0
|
-4.2 mg/dL
Interval -14.7 to 6.1
|
Adverse Events
LSC + Blinded CGM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LSC+TLE + Blinded CGM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LSC+TLE+ Real Time Feedback Via CGM
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