Time-Restricted Eating With Exercise (TRE)

The Effects of Different Time-Restricted Eating Schedules With Exercise on the Body Composition in Overweight Adults

The purpose of the study is to determine if body composition differs between early time restricted eating (8-hour feeding period from 7 am to 3 pm) with exercise and late time restricted eating (8-hour feeding period from 3 pm to 11 pm) with exercise in overweight adults.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Other: Time Restricted Eating

Detailed Description

Time-restricted eating (TRE) is a hot trend in weight-loss diets. TRE can reduce cardio-metabolic risks, thereby lowering body weight, blood pressure, lipid profile, glucose, and inflammation. The most effective way for the overweight population to improve body composition is to incorporate TRE with exercise. However, there were only two TRE interventions in humans that included exercise, suggesting that the additive effect of TRE to exercise may be dependent on dietary timing. TRE can be divided into early TRE (eTRE) and late TRE (lTRE), depending on the time of day of the eating window. However, whether different TRE schedules with exercise can improve cardio-metabolic health is questionable. There have been no interventions of different TRE schedules with exercise. This study will be beneficial for determining which TRE schedule with exercise is efficacious to prevent cardio-metabolic disease.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jinkyung Park, Dr.; Phone Number: 478-445-3930; Email: jinkyung.park@gcsu.edu

Study Locations

• United States
  • Georgia
    • Milledgeville, Georgia, United States, 31061
      • Recruiting
      • Exercise Science Laboratory
      • Contact: Jinkyung Park, Dr.; Phone Number: 478-445-3930; Email: jinkyung.park@gcsu.edu
  • New York
    • Syracuse, New York, United States, 13244
      • Recruiting
      • Clinical Research Laboratory
      • Contact: Joon Young Kim, Dr.; Phone Number: 315-443-1411; Email: jkim291@syr.edu
  • Texas
    • Wichita Falls, Texas, United States, 76308
      • Recruiting
      • Anatomical Laboratory
      • Contact: Soon-mi Choi, Dr.; Phone Number: 940-397-4956; Email: soonmi.choi@msutexas.edu

Participation Criteria

Eligibility Criteria

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

Description

Lists of inclusion criteria: the participants will be allowed to participate in this study if they

1. are adults, aged between 18-30 years
2. are apparently healthy and physically inactive (defined as any form of physical activity performed < 2 days per week)
3. are overweight (BMI 25-<30 kg/m2)
4. are non-smokers
5. are free from the following chronic medical conditions: heart disease, arrhythmias, diabetes, thyroid disease, bleeding disorder, history of pulmonary disease, hypertension, hepatorenal disease, musculoskeletal disorder, neuromuscular/neurological disease, autoimmune disease, cancer, peptic ulcers, anemia, or chronic infection (HIV)
6. are free from the orthopedic conditions that would hinder physical activity
7. have not taken any heart, pulmonary, thyroid, anti-hyperlipidemic, hypoglycemic, anti-hypertensive, endocrinological (e.g, thyroid, insulin, etc), emotional/psychotropic (e.g,Prednisone, Ritalin, Adderall), neuromuscular/neurological, or androgenic medications(anabolic steroids)
8. have low risk for cardiovascular disease and with no contraindications to exercise as outlined by the American College of Sports Medicine (ACSM) will be included.

Lists of exclusion criteria: the participants will not be allowed to participate in this study if they

1. are younger than 18 years and older than 30 years.
2. have consumed any medication for chronic medical condition.
3. are participating in weight management programs.
4. have constrictions to exercise.
5. are currently exercising regularly (at least 2 days per week).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Time Restricted Eating; 8-hour eating period from 7 am to 3 pm with exercise	Other: Time Restricted Eating; Time restricted eating (TRE) can be divided into early TRE (eTRE) and late TRE (lTRE), depending on the time of day of the eating window.
Experimental: Late Time Restricted Eating; 8-hour eating period from 3 pm to 11 pm with exercise	Other: Time Restricted Eating; Time restricted eating (TRE) can be divided into early TRE (eTRE) and late TRE (lTRE), depending on the time of day of the eating window.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in body composition on the dual-energy X-ray absorptiometry (DXA) at week 10	The DXA is a validated instrument, assessing fat, soft tissue, and bone mass.	Baseline and Week 10

Collaborators and Investigators

• Sponsor: Georgia College and State University
• Investigators: Principal Investigator: Jinkyung Park, Dr., Georgia College and State University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: FRG202132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No