Time-restricted Eating Acceptability, Efficacy and Safety in Obesity

University of Mississippi, Oxford46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Time Restricted Eating

Interventions

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Adherence

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

Time frame: 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.

Time frame: During baseline week and week 8 of the intervention

Secondary Outcomes

Body weight (kg)

Pre and post intervention measures of body weight.

Time frame: At baseline and at the end of 8 weeks of intervention

24-hour physical activity energy expenditure (PAEE)

GT9X Actigraph accelerometer will be used over 7 days to measure physical activity energy expenditure pre-intervention and during week 8 of the intervention.

Time frame: During baseline week and week 8 of the intervention

Body fat percentage (%)

Pre and post intervention measurements of body fat percentage measured by bioelectrical impedance analyzer.

Time frame: At baseline and at the end of 8 weeks of intervention

Fat-free mass (kg)

Pre and post intervention measurements of body fat-free mass (kg) measured by bioelectrical impedance analyzer.

Time frame: At baseline and at the end of 8 weeks of intervention

Fat mass (kg)

Pre and post intervention measurements of body fat mass (kg) measured by bioelectrical impedance analyzer.

Time frame: At baseline and at the end of 8 weeks of intervention

Hunger and satiety

Pre and post intervention subjective measure of hunger and satiety with the use of a Hunger and Satiety Visual Analog Scale

Time frame: During baseline week and week 8 of the intervention

Sleep quality

Pre and post intervention measure of subjective sleep quality by use of Pittsburgh Sleep Quality Scale.

Time frame: One time during the baseline week and week 8 of the intervention

Diet Quality

Pre and post intervention measurements of diet quality based on three 24-hour food recall surveys at pre- and post collected using the NDSR software and Healthy Eating Index was calculated.

Time frame: During baseline week and week 8 of the intervention

Perceptions of health and well-being

Pre- and post quality of life will be assessed using RAND 36-Item Health Survey 1.0 (SF-36)

Time frame: At baseline and at the end of 8 weeks of intervention

Weight Bias Internalization

Pre- and post weight bias internalization will be assessed using the Weight Bias Internalization Scale (WBIS).

Time frame: At baseline and at the end of 8 weeks of intervention

Disordered eating risk

Pre- and post disordered eating risk will be assessed using Eating Attitude Test (EAT-26) survey scores

Time frame: At baseline and at the end of 8 weeks of intervention

Eating Behavior

Pre and post eating behavior will be assessed using the Three Factor Eating Questionnaire (TFEQ-18). The TFEQ-R18 measures 3 aspects of eating behavior: cognitive restraint, uncontrolled eating, and emotional eating

Time frame: At baseline and at the end of 8 weeks of intervention

Skin carotenoid

Pre- and post skin carotenoid levels will be measured pre and post-intervention using a non-invasive NuSkin Biophotonic scanner which is based on the Resonant Raman Spectroscopy technology.

Time frame: At baseline and at the end of 8 weeks of intervention

Motivators, barriers, and facilitators for following time restricted eating

Motivators, barriers, and facilitators when following time restricted eating will be assessed only in the TRE group. These will be collected as qualitative data in the format of a semi-structured interviews over Zoom.

Time frame: At end of 2nd week and during the 8th week of intervention.

Time-restricted Eating Acceptability, Efficacy and Safety in Obesity

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts