Actively Recruiting
Time-restricted Eating Acceptability, Efficacy and Safety in Obesity
Led by University of Mississippi, Oxford · Updated on 2024-12-06
46
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 kg/m2 or higher and high body fat percentage (≥25% for males and ≥35% for females)
- Sedentary lifestyle with 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 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 past 3 months), Crohn's disease, Ulcerative Colitis, arthritis, active cancer treatment (except non-melanoma cancer), uncontrolled psychiatric disorder with hospitalization history
- Currently taking medications affecting appetite
- On anabolic steroids or hormone replacement therapy
- Participation in exercise, nutrition, or weight-loss program within last 6 months
- History of surgical weight management
- Body 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 EAT-26 score above 20
- Alcohol or drug addiction
- Current smoker
- Works night shifts
- Unable to commit to 9-week study
- Not willing to follow study protocol
- Following restrictive diets such as Keto, low carbohydrate, vegan, vegetarian, intermittent fasting, paleo, calorie restriction, or others
- Participating in another study
AI-Screening
AI-Powered Screening
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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
CONTACT
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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