TRE: Time-Restricted Eating With Exercise

• Sponsor: Georgia College and State University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05486702
• Collaborator: (none)
• Enrollment: 30
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 9
• Patients Per Site: 10
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: Time Restricted Eating	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The Effects of Different Time-Restricted Eating Schedules With Exercise on the Body Composition in Overweight Adults
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change from baseline in body composition on the dual-energy X-ray absorptiometry (DXA) at week 10 [Baseline and Week 10]

   The DXA is a validated instrument, assessing fat, soft tissue, and bone mass.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Exercise Science Laboratory	Milledgeville	Georgia	United States	31061
2	Clinical Research Laboratory	Syracuse	New York	United States	13244
3	Anatomical Laboratory	Wichita Falls	Texas	United States	76308

Sponsors and Collaborators

• Georgia College and State University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jinkyung Park, Assistant Professor, Georgia College and State University
• ClinicalTrials.gov Identifier: NCT05486702
• Other Study ID Numbers: FRG202132
• First Posted: Aug 3, 2022
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 3, 2022