Clinical trial NCT05486702: Time-Restricted Eating With Exercise
Official title: The Effects of Different Time-Restricted Eating Schedules With Exercise on the Body Composition in Overweight Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: Georgia College and State University
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change from baseline in body composition on the dual-energy X-ray absorptiometry (DXA) at week 10
timeFrame: Baseline and Week 10
Secondary outcomes:
Other outcomes:
Locations:
city: Milledgeville
country: United States
facility: Exercise Science Laboratory
state: Georgia
city: Syracuse
country: United States
facility: Clinical Research Laboratory
state: New York
city: Wichita Falls
country: United States
facility: Anatomical Laboratory
state: Texas
Study officials:
affiliation: Georgia College and State University
name: Jinkyung Park, Dr.
role: PRINCIPAL_INVESTIGATOR
References: