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| Name | Class |
|---|---|
| The Coca-Cola Company | INDUSTRY |
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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?
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Energy Flux | Experimental | Energy Flux Exercise Intervention: 7kcal/kg/day at 5 days/week of energy expenditure and matching energy intake |
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| Medium Energy Flux | Experimental | Energy Flux Exercise Intervention: 3.5kcal/kg/day at 5 days/week of energy expenditure and matching energy intake |
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| Low Energy Flux | No Intervention | No Intervention: maintain normal lifestyle |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Energy Flux Exercise Intervention | Other | Comparison of high, medium and low energy flux groups with all groups matching energy intake and expenditure |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in anthropometrics | Changes in lean and fat mass | From baseline to 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in blood lipids | Change in serum triglycerides | Baseline to 6 months |
| Changes in blood lipids | Change in High Density Lipoprotein [HDL] |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Hand, Ph.D | University of South Carolina | Principal Investigator |
| Steven Blair, Ph.D | University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public Health Research Center, University of South Carolina | Columbia | South Carolina | 29201 | United States |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Baseline to 6 months |
| Changes in blood lipids | Change in Low Density Lipoprotein [LDL] | Baseline to 6 months |
| Changes in blood lipids | Change in LDL particle size | Baseline to 6 months |
| Change in functional measurements | Change in cardiorespiratory fitness through graded exercise testing | Baseline to 6 months |
| Change in functional measurements | Change in resting metabolic rate | Baseline to 6 months |
| Changes in markers of systemic inflammation | Change in tumor necrosis factor-alpha [TNF-alpha] | Baseline to 6 months |
| Changes in markers of systemic inflammation | Change in C reactive protein [CRP] | Baseline to 6 months |
| Changes in markers of systemic inflammation | Change in interleukin-6 [IL-6] | Baseline to 6 months |
| Changes in triglyceride / cholesterol transport | Change in Apolipoprotein E [ApoE] | Baseline to 6 months |
| Changes in triglyceride / cholesterol transport | Change in Apolipoprotein B-48 [ApoB-48] | Baseline to 6 months |
| Changes in triglyceride / cholesterol transport | Change in Apolipoprotein B-100 [ApoB-100] | Baseline to 6 months |
| Change in the index of fatty acid metabolism | Change in serum 3 hydroxybutyric acid | Baseline to 6 months |
| Changes in carbohydrate metabolism | Change in serum insulin | Baseline to 6 months |
| Changes in carbohydrate metabolism | Change in glucose | Baseline to 6 months |
| Changes in carbohydrate metabolism | Change in hemoglobin A1c [HbA1c] | Baseline to 6 months |
| Changes in energy intake | From Baseline to 6 months |
| Changes in energy expenditure | From Baseline to 6 months |