Actively Recruiting
Time-restricted Eating Acceptability, Efficacy and Safety in Free-living Adults With Obesity
Led by University of Mississippi, Oxford · Updated on 2024-12-06
46
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating time-restricted eating (TRE) in healthy, sedentary adults with obesity aged 19 to 65 years. This randomized controlled trial aims to understand how well participants follow TRE, its acceptability, and safety over 8 weeks. The study compares TRE with a non-fasting control group, focusing on calorie intake and adherence while also looking at hunger, cravings, body composition, diet quality, sleep, and overall well-being. Participants are randomly assigned to either the TRE group or the control group. The TRE group will consume calorie-containing foods and drinks within an 8-hour window each day (between 6 a.m. and 8 p.m.) and fast for the remaining 16 hours, while the control group will maintain their usual eating habits over 12 hours or more. The intervention lasts 8 weeks, following a baseline week, with some flexibility allowed for the eating window start and end times. During the study, participants will be monitored for adherence and calorie intake and assessed on body weight, body fat percentage, fat mass, muscle mass, physical activity, hunger and satiety, sleep quality, diet quality, perceptions of health, weight bias internalization, disordered eating risk, and skin carotenoid levels. Data will be collected at baseline, after 2 weeks, and at the end of the 8-week intervention. Participants should expect regular evaluations and questionnaires to track these outcomes throughout the 9-week study period.
CONDITIONS
Brief Title
Time-restricted Eating Acceptability, Efficacy and Safety in Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 to 65 years
- Owns a smartphone
- Apparently healthy
- BMI of 25 or higher and high body fat percentage (25% or more for males, 35% or more for females)
- Sedentary lifestyle (less than 150 minutes of moderate to vigorous activity per week)
- Self-reported eating interval of 12 hours or more per day
You will not qualify if you...
- Diagnosed diabetes, heart disease, hypertension, hyperlipidemia, stroke, chronic lung, liver, kidney, adrenal, thyroid, Crohn's, ulcerative colitis, arthritis, active cancer treatment (except non-melanoma), or uncontrolled psychiatric disorder
- Taking medications affecting appetite
- Using anabolic steroids or hormone replacement therapy
- Participation in an exercise, nutrition, or weight-loss program in the last 6 months
- History of weight management surgery
- Weight change of 5% or more in last 3 months
- Pregnant, less than 6 months postpartum, breastfeeding, polycystic ovarian syndrome, or irregular menstruation
- Missing limbs, pacemaker, or metal implants
- Eating disorders or high EAT-26 score
- Alcohol or drug addiction
- Current smoker
- Works night shifts
- Unable or unwilling to commit to 9-week study or follow protocol
- Following restrictive diets (keto, low carb, vegan, vegetarian, intermittent fasting, paleo, calorie restriction, or others)
- Participating in another study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants follow a prescribed daily feeding window of 8 hours between 6 a.m. to 8 p.m. for 8 weeks while maintaining their normal exercise and resistance training routines. The control group follows their usual eating patterns over 12 hours or more.
Weekly visits for up to 8 weeks
Trial Site Locations
Total: 1 location
1
Department of Nutrition and Hospitality Management, University of Mississippi
Oxford, Mississippi, United States, 38677
Actively Recruiting
Research Team
N
Nadeeja N Wijayatunga, MBBS, MPhil, PhD, RDN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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