A Study of Time Restricted Eating in Obese Adults
Effects of Time Restricted Eating on Obesity: Comparing Windows of Eating to Achieve Weight Loss in Overweight and Obese Adults; a Pilot Study
1 other identifier
interventional
100
1 country
1
Brief Summary
The purpose of this pilot study is to understand the difference between early and late time-restricted eating on weight and body mass index (BMI), and evaluate the barriers encountered and the effect on quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2022
CompletedFirst Posted
Study publicly available on registry
December 21, 2022
CompletedStudy Start
First participant enrolled
February 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
September 26, 2025
September 1, 2025
3.5 years
December 13, 2022
September 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in weight
Reported in kilograms (kg)
Baseline, 12 weeks
Secondary Outcomes (7)
Change in Hemoglobin A1c
Baseline, 12 weeks
Change in fasting glucose
Baseline, 12 weeks
Change in total cholesterol
Baseline, 12 weeks
Change in Low-density lipoprotein (LDL) cholesterol
Baseline, 12 weeks
Change in High-density lipoprotein (HDL) cholesterol
Baseline, 12 weeks
- +2 more secondary outcomes
Study Arms (2)
Early time-restricted eating
EXPERIMENTALSubjects window for eating would be between 08:00 AM - 4:00 PM
Late time-restricted eating
EXPERIMENTALSubjects window for eating would be between 12:00 PM (noon) and 8:00 PM
Interventions
Subjects can eat whatever they want between the hours of 8:00 AM and 4:00 PM and can only consume water, black coffee/tea, or other zero calorie drinks (artificial sweeteners are okay) outside your designated eating window (from 4:00 PM to 8:00 AM).
Subjects can eat whatever they want between the hours of 12:00 PM and 8:00 PM and can only consume water, black coffee/tea, or other zero calorie drinks (artificial sweeteners are okay) outside your designated eating window (from 8:00 PM to noon).
Eligibility Criteria
You may qualify if:
- Ability to read and understand English
- BMI ≥ to 25.
You may not qualify if:
- Regularly skip meals.
- Are unwilling or unable to limit eating to an 8-hour window.
- Have a current Melanoma or cancer diagnosis.
- Currently breastfeeding.
- Pregnant, or planned to be pregnant within 3 months.
- Are taking insulin or sulfonylurea drugs.
- Are taking weight loss medications or had weight loss surgery within the last year.
- Have a history of eating disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic Minnesota
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bradley Bohn, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 13, 2022
First Posted
December 21, 2022
Study Start
February 24, 2023
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
September 26, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share