NCT06695988Completed
Time-restricted Eating Acceptability, Efficacy and Safety in Obesity
Time-restricted Eating Acceptability, Efficacy and Safety in Free-living Adults With Obesity
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
A randomized controlled trial to determine adherence, acceptability and safety of time restricted eating (TRE) in healthy, sedentary, free-living adults with obesity between the ages of 19-65 years when following 16:8 TRE for 8 weeks. This 9-week study includes a baseline week and 8 weeks of the intervention period. Participants are randomly assigned to the TRE or the non-fasting control group. The TRE group will consume calorie containing food and drink only over an 8 hour period and rest of the 16 hour would be fasting. Adherence to TRE and calorie intake are the primary outcomes. Motivators, facilitators and barriers to TRE, hunger and cravings levels, weight bias internalization, body composition (weight, body fat%, fat mass and muscle mass) , Healthy Eating Index (HEI) to assess diet quality, skin carotenoid levels, disordered eating risk, sleep quality, and perceptions of health and well-being are secondary outcomes.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 15 Nov 2024
- Start date
- 18 Jun 2024
- Primary completion date
- 28 Aug 2025
- Lead sponsor
- University of Mississippi, Oxford
- Diseases
- Obesity
- NCT number
- NCT06695988
What you commit to
- Study type: Interventional
- Participants enrolled: 44
- From 18 Jun 2024 to the primary completion date, 28 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking any medication that is meant for, or has a known effect on, appetite
- On anabolic steroid or hormone replacement therapy
- missing limbs, have a pacemaker or metal implants,
- Alcohol or drug addiction
Other illness
- 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).
- Any history of surgical intervention for weight management
- Pregnant or less than 6 months post-partum, breastfeeding, polycystic ovarian syndrome or irregular menstruation
- eating disorders or EAT-26 score \>20
Other
- Participation in an exercise/nutrition/ weight-loss program within the last 6 months
- Having a ≥5% body weight change during the last 3 months
- 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
Who the study is looking for
- 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
Age in the registry: 19 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Nutrition and Hospitality Management, University of Mississippi Coordinator of this site? Confirm its status | Oxford | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.