Time-restricted Eating Acceptability, Efficacy and Safety in Obesity

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Trial completed Show 6 more changesShow less
    • Study completion date changed from estimate of Oct 31, 2025 to Aug 28, 2025
    • Enrollment target: estimated 46 to confirmed 44
    • Start date: Jun 1, 2024 to Jun 18, 2024
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 2 of 14 entries
    • Site details revised
  2. Secondary endpoints revised (14)
    • Eligibility criteria expanded, about 4 words
    v2
  3. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06695988
Lead Sponsor University of Mississippi, Oxford
Conditions
(from sponsor)		 Time Restricted Eating, Obesity
Related terms Intermittent Fasting, Obesity
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov