Clinical trial NCT06695988: Time-restricted Eating Acceptability, Efficacy and Safety in Obesity
Official title: Time-restricted Eating Acceptability, Efficacy and Safety in Free-living Adults With Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Time Restricted Eating
Keywords: Time Restricted Eating
Obesity
Intervention
9 weeks
Randomization
Intermittent fasting
Lead sponsor: University of Mississippi, Oxford
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 46
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Adherence
timeFrame: 8 weeks
measure: Total calorie intake
timeFrame: During baseline week and week 8 of the intervention
Secondary outcomes:
measure: Body weight (kg)
timeFrame: At baseline and at the end of 8 weeks of intervention
measure: 24-hour physical activity energy expenditure (PAEE)
timeFrame: During baseline week and week 8 of the intervention
measure: Body fat percentage (%)
timeFrame: At baseline and at the end of 8 weeks of intervention
measure: Fat-free mass (kg)
timeFrame: At baseline and at the end of 8 weeks of intervention
measure: Fat mass (kg)
timeFrame: At baseline and at the end of 8 weeks of intervention
measure: Hunger and satiety
timeFrame: During baseline week and week 8 of the intervention
measure: Sleep quality
timeFrame: One time during the baseline week and week 8 of the intervention
measure: Diet Quality
timeFrame: During baseline week and week 8 of the intervention
measure: Perceptions of health and well-being
timeFrame: At baseline and at the end of 8 weeks of intervention
measure: Weight Bias Internalization
timeFrame: At baseline and at the end of 8 weeks of intervention
measure: Disordered eating risk
timeFrame: At baseline and at the end of 8 weeks of intervention
measure: Eating Behavior
timeFrame: At baseline and at the end of 8 weeks of intervention
measure: Skin carotenoid
timeFrame: At baseline and at the end of 8 weeks of intervention
measure: Motivators, barriers, and facilitators for following time restricted eating
timeFrame: At end of 2nd week and during the 8th week of intervention.
Other outcomes:
Locations:
city: Oxford
country: United States
facility: Department of Nutrition and Hospitality Management, University of Mississippi
state: Mississippi
Study officials:
References: