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: 1. How does the timing of the eating window (early vs late time restricted eating) affect weight loss and changes in metabolic risk factors? 2. 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. 1. They will be asked to follow the assigned dietary strategy for 1 year and will receive a group-based program for instruction and support. 2. 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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
162
Participants will be instructed to eat only during an 8-hour window starting 1-2 hours after waking.
Participants will be instructed to eat only during an 8-hour window starting 5-6 hours after waking.
Participants will be instructed to reduce caloric intake by 25%.
University of Colorado Anschutz Health and Wellness Center
Aurora, Colorado, United States
RECRUITINGBody weight (kg)
Body weight will be measured using a digital scale at baseline, weeks 14, 26 and 52. The primary outcome will be change in weight from baseline to 26 weeks.
Time frame: 0 to 52 weeks
Fat mass
Fat mass will assessed using Dual-Energy X-Ray Absorptiometry (DXA) at baseline, weeks 14, 26 and 52
Time frame: 0 to 52 weeks
Lean mass
Lean mass will assessed using Dual-Energy X-Ray Absorptiometry (DXA) at baseline, weeks 14, 26 and 52
Time frame: 0-52 weeks
Blood pressure
Systolic and diastolic blood pressure will be measured at baseline and weeks 14, 26 and 52
Time frame: 0-52 weeks
HbA1c
HbA1c will be measured at baseline and weeks 14, 26 and 52
Time frame: 0-52 weeks
Insulin sensitivity
Insulin sensitivity measured with oral glucose tolerance test at baseline and weeks 14, 26 and 52
Time frame: 0-52 weeks
24-hour glucose levels
24-hr glucose levels measured with continuous glucose monitor at baseline and weeks 14, 26 and 52
Time frame: 0-52 weeks
Physical activity
Total steps measured with activPal device at baseline and weeks 14, 26 and 52
Time frame: 0-52 weeks
Total cholesterol concentration
Total cholesterol concentration will be measured at baseline and weeks 14, 26 and 52
Time frame: 0-52 weeks
Sleep duration
Sleep duration (minutes) will be measured with activPal device at baseline and weeks 0, 14 and 26
Time frame: 0-52 weeks
LDL cholesterol concentration
Low density lipoprotein (LDL) will be measured at baseline and weeks 14, 26 and 52
Time frame: 0-52 weeks
HDL cholesterol concentration
High density lipoprotein (HDL) cholesterol concentration will be measured at baseline and weeks 14, 26 and 52
Time frame: 0-52 weeks
Triglyceride concentration
Triglyceride concentration will be measured at baseline and weeks 14, 26 and 52
Time frame: 0-52 weeks
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