Effects of Early vs. Late Time Restricted Eating vs. Daily Caloric Restriction on Weight Loss and Metabolic Outcomes in Adults With Obesity

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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.

Locations
United States
Colorado
University of Colorado Anschutz Health and Wellness Center
RECRUITING
Aurora
Contact Information
Primary
Sheila Steinke
sheila.steinke@cuanschutz.edu
303-724-3304
Backup
Emilee Mickaliger
emilee.mickaliger@cuanschutz.edu
Time Frame
Start Date: 2023-07-11
Estimated Completion Date: 2027-09
Participants
Target number of participants: 162
Treatments
Experimental: Early time restricted eating
Participants will asked to follow early time restricted eating
Experimental: Late time restricted eating
Participants will be asked to follow late time restricted eating
Active_comparator: Daily caloric restriction
Participants will be instructed to follow daily caloric restriction
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov

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