Time-restricted Eating Acceptability, Efficacy and Safety in Obesity

University of Mississippi, Oxford

Status: Enrolling

Conditions: Time Restricted Eating

Treatments: Behavioral: Time Restricted Eating

Study type: Interventional

Funder types: Other

Identifiers

NCT06695988

UMississippiO

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Time Restricted Eating Group

Experimental group

Description:

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.

Treatment:

Behavioral: Time Restricted Eating

Control

No Intervention group

Description:

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