Clinical trial

Time-restricted Eating Acceptability, Efficacy and Safety in Obesity

Recruiting now · Not applicable · 1 countries · Registry ID NCT06695988

Recruiting nowNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age19 Years to 65 Years
SexAll
Healthy volunteersAccepted
ConditionTime Restricted Eating

Full registry 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

Treatments and study arms

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

Primary outcomes

Adherence8 weeks

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

Total calorie intakeDuring baseline week and week 8 of the intervention

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Department of Nutrition and Hospitality Management, University of Mississippi🇺🇸 Oxford, Mississippi, United States
Nadeeja N Wijayatunga, MBBS, MPhil, PhD, RDNContact