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Time-restricted Eating Acceptability, Efficacy and Safety in Obesity

NCT06695988 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-12-06

No results posted yet for this study

Summary

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

  • Time Restricted Eating

Interventions

BEHAVIORAL

Time Restricted Eating

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

Sponsors & Collaborators

  • University of Mississippi, Oxford

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-08-31
Completion
2025-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06695988 on ClinicalTrials.gov