The Energy Flux Study
Study Details
Study Description
Brief 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 energy flux as compared to a low energy flux?
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: High Energy Flux Energy Flux Exercise Intervention: 7kcal/kg/day at 5 days/week of energy expenditure and matching energy intake |
Other: Energy Flux Exercise Intervention
Comparison of high, medium and low energy flux groups with all groups matching energy intake and expenditure
|
| Experimental: Medium Energy Flux Energy Flux Exercise Intervention: 3.5kcal/kg/day at 5 days/week of energy expenditure and matching energy intake |
Other: Energy Flux Exercise Intervention
Comparison of high, medium and low energy flux groups with all groups matching energy intake and expenditure
|
| No Intervention: Low Energy Flux No Intervention: maintain normal lifestyle |
Outcome Measures
Primary Outcome Measures
- Changes in anthropometrics [From baseline to 6 months]
Changes in lean and fat mass
Other Outcome Measures
- Changes in blood lipids [Baseline to 6 months]
Change in serum triglycerides
- Changes in blood lipids [Baseline to 6 months]
Change in High Density Lipoprotein [HDL]
- Changes in blood lipids [Baseline to 6 months]
Change in Low Density Lipoprotein [LDL]
- Changes in blood lipids [Baseline to 6 months]
Change in LDL particle size
- Change in functional measurements [Baseline to 6 months]
Change in cardiorespiratory fitness through graded exercise testing
- Change in functional measurements [Baseline to 6 months]
Change in resting metabolic rate
- Changes in markers of systemic inflammation [Baseline to 6 months]
Change in tumor necrosis factor-alpha [TNF-alpha]
- Changes in markers of systemic inflammation [Baseline to 6 months]
Change in C reactive protein [CRP]
- Changes in markers of systemic inflammation [Baseline to 6 months]
Change in interleukin-6 [IL-6]
- Changes in triglyceride / cholesterol transport [Baseline to 6 months]
Change in Apolipoprotein E [ApoE]
- Changes in triglyceride / cholesterol transport [Baseline to 6 months]
Change in Apolipoprotein B-48 [ApoB-48]
- Changes in triglyceride / cholesterol transport [Baseline to 6 months]
Change in Apolipoprotein B-100 [ApoB-100]
- Change in the index of fatty acid metabolism [Baseline to 6 months]
Change in serum 3 hydroxybutyric acid
- Changes in carbohydrate metabolism [Baseline to 6 months]
Change in serum insulin
- Changes in carbohydrate metabolism [Baseline to 6 months]
Change in glucose
- Changes in carbohydrate metabolism [Baseline to 6 months]
Change in hemoglobin A1c [HbA1c]
- Changes in energy intake [From Baseline to 6 months]
- Changes in energy expenditure [From Baseline to 6 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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BMI <35
-
21-45 years of age
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Fasting plasma glucose <126 mg/dl
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Current medications must have been prescribed for 3 or more months and stable
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Internet access
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Able to participate in a somewhat strenuous physical exercise program
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Able to provide informed consent for participation in a research study
Exclusion Criteria:
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Currently participating in a weight loss or exercise intervention / program
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Planning to have weight loss surgery
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Weight change >5 lb in last 12 months
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Currently taking any of the following: hormone replacement therapy, beta blockers, allergy shots or systematic corticosteroids (except inhalers)
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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.
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Medical history with presence of significant conditions or disease that may interfere with study, recent surgery
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Pregnant or actively trying to become pregnant
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Gave birth in the last 12 months or <6 months post-lactation
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90th percentile on the Brief Symptom Inventory [BSI]
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Planning to move from the area in the next 8 months
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Public Health Research Center, University of South Carolina | Columbia | South Carolina | United States | 29201 |
Sponsors and Collaborators
- University of South Carolina
- The Coca-Cola Company
Investigators
- Principal Investigator: Gregory Hand, Ph.D, University of South Carolina
- Principal Investigator: Steven Blair, Ph.D, University of South Carolina
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Energy Flux