Time-restricted Eating Acceptability, Efficacy and Safety in Obesity

Time-restricted Eating Acceptability, Efficacy and Safety in Free-living Adults With Obesity

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 Overview

• Status: Recruiting
• Conditions: Time Restricted Eating
• Intervention / Treatment: Behavioral: Time Restricted Eating

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nadeeja N Wijayatunga, MBBS, MPhil, PhD, RDN; Phone Number: 662 915 1351; Email: nadeejaw@olemiss.edu

Study Locations

• United States
  • Mississippi
    • Oxford, Mississippi, United States, 38677
      • Recruiting
      • Department of Nutrition and Hospitality Management, University of Mississippi
      • Contact: Nadeeja N Wijayatunga, MBBS, MPhil, PhD, RDN; Phone Number: 662 915 1351; Email: nadeejaw@olemiss.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Time Restricted Eating Group; 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; 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
No Intervention: Control; They will follow their usual eating patterns and consume food over a period of 12 hours or more.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight (kg)	Pre and post intervention measures of body weight.	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.	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.	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.	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.	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	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.	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.	During baseline week and week 8 of the intervention
Weight Bias Internalization	Pre- and post weight bias internalization will be assessed using the Weight Bias Internalization Scale (WBIS).	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	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	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.	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.	At end of 2nd week and during the 8th week of 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)	At baseline and at the end of 8 weeks of intervention

Collaborators and Investigators

• Sponsor: University of Mississippi, Oxford

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Actual): November 19, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Randomization; Intervention; Time Restricted Eating; Intermittent fasting; 9 weeks
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: UMississippiO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share the de-identified participant data used in the published manuscripts by depositing these data in a secure data repository. The data shared will include the sociodemographic data and the outcomes published in the manuscripts. The protocol and statistical analysis plan will be shared as supplementary material through the journal where the study if published, if allowed
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No