ObesityTRENCT05486702
Time-Restricted Eating With Exercise
A study testing Time Restricted Eating in people with Obesity, run by Georgia College and State University at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Time Restricted Eating
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2022to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Lists of inclusion criteria: the participants will be allowed to participate in this study if they
- are adults, aged between 18-30 years
- are apparently healthy and physically inactive (defined as any form of physical activity performed < 2 days per week)
- are overweight (BMI 25-<30 kg/m2)
- are non-smokers
- 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)
- are free from the orthopedic conditions that would hinder physical activity
- 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)
- 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
- are younger than 18 years and older than 30 years.
- have consumed any medication for chronic medical condition.
- are participating in weight management programs.
- have constrictions to exercise.
- are currently exercising regularly (at least 2 days per week).
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Exercise Science Laboratory
Milledgeville, Georgia, 31061
Jinkyung Park, Dr., 478-445-3930, jinkyung.park@gcsu.edu
- Recruiting
Clinical Research Laboratory
Syracuse, New York, 13244
Joon Young Kim, Dr., 315-443-1411, jkim291@syr.edu
- Recruiting
Anatomical Laboratory
Wichita Falls, Texas, 76308
Soon-mi Choi, Dr., 940-397-4956, soonmi.choi@msutexas.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Time Restricted Eating
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted EatingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Time Restricted Eating | Experimental | 8-hour eating period from 7 am to 3 pm with exercise Receives: Other: Time Restricted Eating |
| Late Time Restricted Eating | Experimental | 8-hour eating period from 3 pm to 11 pm with exercise Receives: Other: Time Restricted Eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study startAug 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgia College and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinkyung Park, Georgia College and State University
- Investigators
- Jinkyung Park, Dr., Principal investigator, Georgia College and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486702
- Sponsor's protocol ID
- FRG202132
- Acronym
- TRE
- Status last verified
- Aug 2022
- First submitted
- 22 Jun 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Time-Restricted Eating Schedules With Exercise on the Body Composition in Overweight Adults
- ClinicalTrials.gov ID
- NCT05486702
- Acronym / sponsor ID
- TRE / FRG202132
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Georgia College and State UniversityUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Time Restricted Eating | Experimental | Other: Time Restricted Eating8-hour eating period from 7 am to 3 pm with exercise |
| Late Time Restricted Eating | Experimental | Other: Time Restricted Eating8-hour eating period from 3 pm to 11 pm with exercise |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time Restricted EatingTime restricted eating (TRE) can be divided into early TRE (eTRE) and late TRE (lTRE), depending on the time of day of the eating window. | Other | Early Time Restricted Eating, Late Time Restricted Eating |
Primary outcome
Change from baseline in body composition on the dual-energy X-ray absorptiometry (DXA) at week 10
Time frame: Baseline and Week 10
The DXA is a validated instrument, assessing fat, soft tissue, and bone mass.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinkyung Park, Dr. principal investigator
Georgia College and State University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time Restricted Eating in people with Obesity, run by Georgia College and State University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinkyung Park, Dr. (478-445-3930, jinkyung.park@gcsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in body composition on the dual-energy X-ray absorptiometry (DXA) at week 10 (time frame: Baseline and Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.