Time-restricted Eating Acceptability, Efficacy and Safety in Obesity

Part of paid clinical trials in Oxford, Mississippi.

Sponsor
University of Mississippi, Oxford
Study ID
NCT06695988
Status
Recruiting
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Conditions

  • Time Restricted Eating

Eligibility Criteria

Sex
ALL
Age
19 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Time Restricted Eating — BEHAVIORAL
    The intervention group will eat and drink in a prescribed daily feeding window of 8-hour between 6 a.m. to 8 p.m. for 8 weeks and follow their normal exercise and resistance training routines. We will allow +/-1 hour starting and ending times for the eating window while aiming for an 8-hour eating window

Study Details

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.

Key Dates

Start date
Jun 1, 2024
Status verified
Dec 2024
Primary completion
Aug 31, 2025
Completion
Oct 31, 2025

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Time Restricted Eating Group
    The TRE group will consume calorie-containing food and drinks only over an 8-hour window between 6 a.m. to 8 p.m. for 8 weeks. During the fasting period, they can take only calorie-free fluids.
  • No Intervention: Control
    They will follow their usual eating patterns and consume food over a period of 12 hours or more.

Primary Outcome Measure

Adherence [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Department of Nutrition and Hospitality Management, University of MississippiOxfordMississippi38677
Nadeeja N Wijayatunga, MBBS, MPhil, PhD, RDN
[email protected]
662 915 1351

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By research site
Department of Nutrition and Hospitality Management, University of Mississippi· Oxford, MS

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