Physical ActivityNCT01736098
The Energy Flux Study
A study testing Energy Flux Exercise Intervention in people with Physical Activity, run by University of South Carolina at 1 site in United States.
Trial summary
The focus of this randomized clinical trial study is an examination of the effects of maintaining energy balance at different energy fluxes. It will address the primary question: Are there increased health benefits related to body composition and metabolic function associated with maintaining energy balance at a high… Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Energy Flux Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 2014
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI <35
- 21-45 years of age
- Fasting plasma glucose <126 mg/dl
- Current medications must have been prescribed for 3 or more months and stable
- Internet access
- Able to participate in a somewhat strenuous physical exercise program
- Able to provide informed consent for participation in a research study
Who cannot join
- Currently participating in a weight loss or exercise intervention / program
- Planning to have weight loss surgery
- Weight change >5 lb in last 12 months
- Currently taking any of the following: hormone replacement therapy, beta blockers, allergy shots or systematic corticosteroids (except inhalers)
- Significant cardiovascular disease or disorders including but not limited to: serious arrhythmias, cardiomyopathy, congestive heart failure, stroke or transient ischemic cerebral attacks, peripheral vascular disease with intermittent claudication, acute, chronic or recurrent thrombophlebitis, Stage II or Stage III hypertension, myocardial infarction or abnormal exercise stress test.
- Medical history with presence of significant conditions or disease that may interfere with study, recent surgery
Show all 11Show fewer
- Pregnant or actively trying to become pregnant
- Gave birth in the last 12 months or <6 months post-lactation
- > 90th percentile on the Brief Symptom Inventory [BSI]
- Planning to move from the area in the next 8 months
- Other medical, psychiatric or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability ot follow the intervention protocol. Upon identification of individuals with suicidal ideation or other dangerous conditions, the individual will be contacted and told to immediately go to a medical emergency room.
Trial locations and contacts
1 site in 1 country.
United States1 site
Public Health Research Center, University of South Carolina
Columbia, South Carolina, 29201
About this study
Official title: Evaluation of Energy Balance at High vs. Low Energy Flux - Energy Flux Study
The focus of this randomized clinical trial study is an examination of the effects of maintaining energy balance at different energy fluxes. It will address the primary question: Are there increased health benefits related to body composition and metabolic function associated with maintaining energy balance at a high energy flux as compared to a low energy flux?
Read the detailed description
We will randomly assign 75 sedentary but healthy individuals to one of two exercise groups or a non-exercise group. We will follow the individuals for 6 months during the intervention period. Both groups will maintain weight by matching energy intake and expenditure (thus the exercise group will consume more calories).
- Conditions
- Physical Activity
- Being tested
- Energy Flux Exercise Intervention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy Flux Exercise InterventionOther
Comparison of high, medium and low energy flux groups with all groups matching energy intake and expenditure
| Study group | Role | What they receive |
|---|---|---|
| High Energy Flux | Experimental | Energy Flux Exercise Intervention: 7kcal/kg/day at 5 days/week of energy expenditure and matching energy intake Receives: Other: Energy Flux Exercise Intervention |
| Medium Energy Flux | Experimental | Energy Flux Exercise Intervention: 3.5kcal/kg/day at 5 days/week of energy expenditure and matching energy intake Receives: Other: Energy Flux Exercise Intervention |
| Low Energy Flux | No intervention | No Intervention: maintain normal lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in anthropometrics
Changes in lean and fat mass
Measured: From baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- The Coca-Cola Company
- Responsible party
- Principal investigator, Sarah Schumacher, University of South Carolina
- Investigators
- Gregory Hand, Ph.D, Principal investigator, University of South CarolinaSteven Blair, Ph.D, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736098
- Sponsor's protocol ID
- Pro00018017
- Status last verified
- Feb 2023
- First submitted
- 15 Nov 2012
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Energy Balance at High vs. Low Energy Flux - Energy Flux Study
- ClinicalTrials.gov ID
- NCT01736098
- Acronym / sponsor ID
- Pro00018017
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- The Coca-Cola Company
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 29 Nov 2012 (estimated)
- 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 focus of this randomized clinical trial study is an examination of the effects of maintaining energy balance at different energy fluxes. It will address the primary question: Are there increased health benefits related to body composition and metabolic function associated with maintaining energy balance at a high energy flux as compared to a low energy flux?
Detailed description
We will randomly assign 75 sedentary but healthy individuals to one of two exercise groups or a non-exercise group. We will follow the individuals for 6 months during the intervention period. Both groups will maintain weight by matching energy intake and expenditure (thus the exercise group will consume more calories).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Energy Flux | Experimental | Other: Energy Flux Exercise InterventionEnergy Flux Exercise Intervention: 7kcal/kg/day at 5 days/week of energy expenditure and matching energy intake |
| Medium Energy Flux | Experimental | Other: Energy Flux Exercise InterventionEnergy Flux Exercise Intervention: 3.5kcal/kg/day at 5 days/week of energy expenditure and matching energy intake |
| Low Energy Flux | No intervention | –No Intervention: maintain normal lifestyle |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- BMI <35
- 21-45 years of age
- Fasting plasma glucose <126 mg/dl
- Current medications must have been prescribed for 3 or more months and stable
- Internet access
Key exclusion criteria (11 listed)
- Currently participating in a weight loss or exercise intervention / program
- Planning to have weight loss surgery
- Weight change >5 lb in last 12 months
- Currently taking any of the following: hormone replacement therapy, beta blockers, allergy shots or systematic corticosteroids (except inhalers)
- Significant cardiovascular disease or disorders including but not limited to: serious arrhythmias, cardiomyopathy, congestive heart failure, stroke or transient ischemic cerebral attacks, peripheral vascular disease with intermittent claudication, acute, chronic or recurrent thrombophlebitis, Stage II or Stage III hypertension, myocardial infarction or abnormal exercise stress test.
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 |
|---|---|---|
| Energy Flux Exercise InterventionComparison of high, medium and low energy flux groups with all groups matching energy intake and expenditure | Other | High Energy Flux, Medium Energy Flux |
Primary outcome
Changes in anthropometrics
Time frame: From baseline to 6 months
Changes in lean and fat mass
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
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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.
Gregory Hand, Ph.D principal investigator
University of South Carolina
Steven Blair, Ph.D principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy Flux Exercise Intervention in people with Physical Activity, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in anthropometrics (time frame: From baseline to 6 months). 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 13 Feb 2023.