Time-restricted Eating Acceptability, Efficacy and Safety in Obesity

NCT ID: NCT06695988

Last Updated: 2024-12-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-10-31

Brief 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

Keywords

Time Restricted Eating; Obesity; Intervention; 9 weeks; Randomization; Intermittent fasting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Time Restricted Eating

Intervention Type: 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

Control

They will follow their usual eating patterns and consume food over a period of 12 hours or more.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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 the past 3 months), Crohn's disease, Ulcerative Colitis, arthritis, undergoing active cancer treatment except for non-melanoma cancer, uncontrolled psychiatric disorder (a history of hospitalization for psychiatric illness).
• Currently taking any medication that is meant for, or has a known effect on, appetite
• On anabolic steroid or hormone replacement therapy
• Participation in an exercise/nutrition/ weight-loss program within the last 6 months
• Any history of surgical intervention for weight management
• Having a ≥5% body weight change during the last 3 months
• Pregnant or less than 6 months post-partum, breastfeeding, polycystic ovarian syndrome or irregular menstruation
• missing limbs, have a pacemaker or metal implants,
• eating disorders or EAT-26 score >20
• Alcohol or drug addiction
• Current smoker
• Works night shifts
• Unable to commit to a 9-week study
• Not willing to follow study protocol and any other contraindications.
• Currently following any of the following restrictive diets - Keto/low carbohydrate/ Vegan/ Vegetarian/ Intermittent fasting/ Paleo/ Calorie restriction/ Any other restrictive diet
• Participating in another study

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Mississippi, Oxford

OTHER

Sponsor Role: lead

Responsible Party

Nadeeja Wijayatunga

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Nutrition and Hospitality Management, University of Mississippi

Oxford, Mississippi, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nadeeja N Wijayatunga, MBBS, MPhil, PhD, RDN

Role: CONTACT

Phone: 662 915 1351

Email: nadeejaw@olemiss.edu

Facility Contacts

Nadeeja N Wijayatunga, MBBS, MPhil, PhD, RDN

Role: primary

Other Identifiers

UMississippiO

Identifier Type: -

Identifier Source: org_study_id