Exploring time-restricted eating for obesity management
Time-restricted Eating Acceptability, Efficacy and Safety in Free-living Adults With Obesity
This study is testing if time-restricted eating can help adults with obesity manage their weight and improve their health over nine weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 19 Years to 65 Years |
| Sex | All |
| Sponsor | University of Mississippi, Oxford Academic / other |
| Locations | 1 site (Oxford, Mississippi) |
| Trial ID | NCT06695988 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the acceptability, efficacy, and safety of time-restricted eating (TRE) in healthy adults with obesity. Participants aged 19-65 will be randomly assigned to either a TRE group, where they will eat within an 8-hour window, or a non-fasting control group over a 9-week period. The study aims to assess adherence to the TRE regimen, calorie intake, and various health metrics, including body composition and diet quality. Secondary outcomes will explore factors influencing adherence and overall well-being.
Who should consider this trial
Good fit: Ideal candidates are healthy, sedentary adults aged 19-65 with a BMI of 25 or higher and a high body fat percentage.
Not a fit: Patients with diagnosed chronic diseases, uncontrolled psychiatric disorders, or those on specific medications affecting appetite may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide an effective dietary strategy for weight management in individuals with obesity.
How similar studies have performed: Previous studies on time-restricted eating have shown promising results, indicating potential effectiveness in weight management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 19 to 65 years * Owns a smartphone * Apparently healthy * BMI ( more than or equal to 25 kg/m2 ) and high body fat percent (BF%) (≥25% and ≥35% for males and females, respectively) * Sedentary lifestyle (less than 150 minutes of self-reported moderate to vigorous activity per week) * Self-reported eating interval of ≥12 h per day Exclusion Criteria: * Diagnosed diabetes mellitus (type I or II), coronary heart disease, heart failure, hypertension, hyperlipidemia, stroke, chronic lung diseases, liver or kidney disease, adrenal diseases, musculoskeletal disorders, uncontrolled thyroid disease (dose changes within the past 3 months), Crohn's disease, Ulcerative Colitis, arthritis, undergoing active cancer treatment except for non-melanoma cancer, uncontrolled psychiatric disorder (a history of hospitalization for psychiatric illness). * Currently taking any medication that is meant for, or has a known effect on, appetite * On anabolic steroid or hormone replacement therapy * Participation in an exercise/nutrition/ weight-loss program within the last 6 months * Any history of surgical intervention for weight management * Having a ≥5% body weight change during the last 3 months * Pregnant or less than 6 months post-partum, breastfeeding, polycystic ovarian syndrome or irregular menstruation * missing limbs, have a pacemaker or metal implants, * eating disorders or EAT-26 score \>20 * Alcohol or drug addiction * Current smoker * Works night shifts * Unable to commit to a 9-week study * Not willing to follow study protocol and any other contraindications. * Currently following any of the following restrictive diets - Keto/low carbohydrate/ Vegan/ Vegetarian/ Intermittent fasting/ Paleo/ Calorie restriction/ Any other restrictive diet * Participating in another study
Where this trial is running
Oxford, Mississippi
- Department of Nutrition and Hospitality Management, University of Mississippi — Oxford, Mississippi, United States (Recruiting)
Study contacts
- Study coordinator: Nadeeja N Wijayatunga, MBBS, MPhil, PhD, RDN
- Email: nadeejaw@olemiss.edu
- Phone: 662 915 1351
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.