Determine the effectiveness of how limiting the time you eat within an early or late eating window and fasting for remainder of the day will impact weight loss and body mass index (BMI).
In adults, there is growing evidence that early TRE is more effective in improving metabolic outcomes than other forms of TRE, however it is unclear whether adolescents will be able to adhere to such recommendations. Hence, in the present study we propose a 24-week, 2-arm, parallel randomized pilot trial in 100 adolescents (age 13-18 years, all gender expressions, anticipate 65% Latino) with obesity, to test the preliminary efficacy of early vs. late TRE on glycemic profiles, weight loss, and body composition. We hypothesize that, among adolescents who can adhere to the meal timing recommendations, early TRE will result in greater improvement in metabolic endpoints than late TRE. We will test the hypothesis with 3 specific aims: Aim 1: Test the effect of early vs. late TRE on glycemic profiles and β-cell function. Aim 2: Test the effect of early vs. late TRE on obesity and body composition, and cardiometabolic risk factors. Aim 3: Test the effect of early vs. late TRE on exploratory outcomes including sleep, physical activity, and dietary intake to explore how meal timing may influence occurrence, timing, and distribution of sleep and movement as well as dietary intake and caloric distribution. This study is the first study evaluating the effectiveness of early vs. late TRE in adolescents with obesity at risk for diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
94
Early Time Restricted Eating 7 AM to 3 PM
Late Time Restricted Eating 12 PM to 8 PM
Children's Hospital Los Angeles
Los Angeles, California, United States
Mean change in weight in excess of the 95th percentile at week 24 compared to baseline
Change in weight in excess of the 95th percentile
Time frame: week 24
Mean change in total body fat mass as measured on DEXA scan at week 24 compared to baseline
Change in total body fat mass measured on DEXA scan
Time frame: week 24
Mean change in percent time in range as captured on contiguous glucose monitor at week 24 compared to baseline
%TIR captured on CGM
Time frame: week 24
Mean change in hemoglobin A1c at week 24 compared to baseline
HgA1c measured at baseline and week 24
Time frame: week 24
Mean change in ALT at week 24 compared to baseline
ALT measured at baseline and week 24
Time frame: week 24
Mean change in systolic and diastolic blood pressure at week 24 compared to baseline
Measured systolic and diastolic blood pressure at baseline and week 24
Time frame: week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.