Time-restricted Eating Acceptability, Efficacy and Safety in Obesity

NCT06695988 | Recruiting

• 1 other identifier: UMississippiO
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Adherence

  Percent of days during the 8-week trial when TRE was adhered to as recommended. This will be self-reported daily.

  8 weeks

• Total calorie intake

  Pre and post intervention measurements of calorie intake based on three 24-hour food recall surveys using the NDSR software.

  During baseline week and week 8 of the intervention

Secondary Outcomes (14)

• Body weight (kg)

  At baseline and at the end of 8 weeks of intervention

• 24-hour physical activity energy expenditure (PAEE)

  During baseline week and week 8 of the intervention

• Body fat percentage (%)

  At baseline and at the end of 8 weeks of intervention

• Fat-free mass (kg)

  At baseline and at the end of 8 weeks of intervention

• Fat mass (kg)

  At baseline and at the end of 8 weeks of intervention

Study Arms (2)

Time Restricted Eating Group

EXPERIMENTAL

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.

Behavioral: Time Restricted Eating

Control

NO INTERVENTION

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

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

Time Restricted Eating Group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mississippi, Oxford: lead

Study Sites (1)

Department of Nutrition and Hospitality Management, University of Mississippi

Oxford, Mississippi, 38677, United States

RECRUITING

MeSH Terms

Conditions

Intermittent Fasting; Obesity

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nadeeja N Wijayatunga, MBBS, MPhil, PhD, RDN

CONTACT

662 915 1351; nadeejaw@olemiss.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: June 1, 2024
• Primary Completion: August 31, 2025
• Study Completion: October 31, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)