Overweight and Obesity
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALEarly TRE
Participants will be instructed to eat only during an 8-hour window starting 1-2 hours after waking.
BEHAVIORALLate TRE
Participants will be instructed to eat only during an 8-hour window starting 5-6 hours after waking.
BEHAVIORALDCR
Participants will be instructed to reduce caloric intake by 25%.
Sponsors
University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
randomized, parallel-arm clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult males and females with a BMI of 27-45 kg/m2 * Age, 18-65 years old * Passing medical and physical screening, and analysis of blood and urine screening samples * Individuals who are not currently following an intermittent fasting or TRE dietary regimen (i.e., eating across less than a 10-hour period during the day). * Own a smartphone * Live or work within 45 minutes of the Anschutz Health \& Wellness Center (exceptions may be made at the discretion of the Study PI on a case-by-case basis for highly motivated subjects) * No plans to relocate within the next 12 months * Capable and willing to give informed consent, understand
Exclusion criteria
, and accept the randomized group assignment. * Have a primary care physician (or are willing to establish care with a primary care physician prior to study enrollment) to address medical issues which may arise during screening or study procedures/interventions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight (kg) | 0 to 52 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fat mass | 0 to 52 weeks | Fat mass will assessed using Dual-Energy X-Ray Absorptiometry (DXA) at baseline, weeks 14, 26 and 52 |
| Lean mass | 0-52 weeks | Lean mass will assessed using Dual-Energy X-Ray Absorptiometry (DXA) at baseline, weeks 14, 26 and 52 |
| Blood pressure | 0-52 weeks | Systolic and diastolic blood pressure will be measured at baseline and weeks 14, 26 and 52 |
| HbA1c | 0-52 weeks | HbA1c will be measured at baseline and weeks 14, 26 and 52 |
| Insulin sensitivity | 0-52 weeks | Insulin sensitivity measured with oral glucose tolerance test at baseline and weeks 14, 26 and 52 |
| 24-hour glucose levels | 0-52 weeks | 24-hr glucose levels measured with continuous glucose monitor at baseline and weeks 14, 26 and 52 |
| Physical activity | 0-52 weeks | Total steps measured with activPal device at baseline and weeks 14, 26 and 52 |
| Total cholesterol concentration | 0-52 weeks | Total cholesterol concentration will be measured at baseline and weeks 14, 26 and 52 |
| Sleep duration | 0-52 weeks | Sleep duration (minutes) will be measured with activPal device at baseline and weeks 0, 14 and 26 |
| LDL cholesterol concentration | 0-52 weeks | Low density lipoprotein (LDL) will be measured at baseline and weeks 14, 26 and 52 |
| HDL cholesterol concentration | 0-52 weeks | High density lipoprotein (HDL) cholesterol concentration will be measured at baseline and weeks 14, 26 and 52 |
| Triglyceride concentration | 0-52 weeks | Triglyceride concentration will be measured at baseline and weeks 14, 26 and 52 |
Countries
United States
Outcome results
None listed