Time-restricted Eating Acceptability, Efficacy and Safety in Free-living Adults With Obesity

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 65
Healthy Volunteers: t
View:

• 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

Locations
United States
Mississippi
Department of Nutrition and Hospitality Management, University of Mississippi
RECRUITING
Oxford
Contact Information
Primary
Nadeeja N Wijayatunga, MBBS, MPhil, PhD, RDN
nadeejaw@olemiss.edu
662 915 1351
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 46
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Mississippi, Oxford

This content was sourced from clinicaltrials.gov