University of Colorado, Denver
The goal of this clinical trial is to learn about time restricted eating as a weight loss intervention in adults with obesity. The main questions it aims to answer are: How does the timing of the eating window (early vs late time restricted eating) affect weight loss and changes in metabolic risk factors? How does time restricted eating compare to standard of care (daily caloric restriction) for weight loss and changes in metabolic risk factors? Participants will be randomly assigned to either early time restricted eating, late time restricted eating, or daily caloric restriction. They will be asked to follow the assigned dietary strategy for 1 year and will receive a group-based program for instruction and support. They will be asked at several times during the year to have their weight and body composition measured, provide blood samples, track their food, and wear monitors for physical activity and sleep.
Overweight and Obesity
Early TRE
Late TRE
DCR
Not Applicable
This is a 52-week randomized, parallel-arm clinical trial designed to assess the effects of early time restricted eating (E-TRE) vs late TRE (L-TRE) vs daily caloric restriction (DCR) within the context of a guidelines-based behavioral weight loss program. 162 adults (age 18-65) with obesity (BMI 27-45 kg/m2) will be recruited from the community and randomized 1:1:1 to E-TRE (eating within an 8-hour window starting 1-2 hours after waking), L-TRE (eating within an 8-hour window starting 5-6 hours after waking) or DCR (caloric restriction of 25% from baseline energy requirements). The primary outcome is change in body weight at 26 weeks. Secondary outcomes include body composition, insulin sensitivity, blood pressure, glucose variability, physical activity, and sleep.}}
Study Type : | Interventional |
Estimated Enrollment : | 162 participants |
Masking : | Single |
Primary Purpose : | Treatment |
Official Title : | Effects of Early vs. Late Time Restricted Eating vs. Daily Caloric Restriction on Weight Loss and Metabolic Outcomes in Adults With Obesity |
Actual Study Start Date : | July 11, 2023 |
Estimated Primary Completion Date : | March 2027 |
Estimated Study Completion Date : | September 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Early time restricted eating Participants will asked to follow early time restricted eating |
Behavioral: Early TRE |
Experimental: Late time restricted eating Participants will be asked to follow late time restricted eating |
Behavioral: Late TRE |
Active Comparator: Daily caloric restriction Participants will be instructed to follow daily caloric restriction |
Behavioral: DCR |
Ages Eligible for Study: | 18 Years to 65 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
University of Colorado Anschutz Health and Wellness Center
Aurora, Colorado, United States, 80045