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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05486702
Other study ID # FRG202132
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 2022
Est. completion date May 2023

Study information

Verified date August 2022
Source Georgia College and State University
Contact Jinkyung Park, Dr.
Phone 478-445-3930
Email jinkyung.park@gcsu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date May 2023
Est. primary completion date December 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Exercise Science Laboratory Milledgeville Georgia
United States Clinical Research Laboratory Syracuse New York
United States Anatomical Laboratory Wichita Falls Texas

Sponsors (1)

Lead Sponsor Collaborator
Georgia College and State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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