Physical Activity
Conditions
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?
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).
Interventions
OTHEREnergy Flux Exercise Intervention
Comparison of high, medium and low energy flux groups with all groups matching energy intake and expenditure
Sponsors
The Coca-Cola Company
University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in anthropometrics | From baseline to 6 months | Changes in lean and fat mass |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in energy expenditure | From Baseline to 6 months | — |
| Changes in markers of systemic inflammation | Baseline to 6 months | Change in tumor necrosis factor-alpha \[TNF-alpha\] |
| Changes in triglyceride / cholesterol transport | Baseline to 6 months | Change in Apolipoprotein E \[ApoE\] |
| Changes in energy intake | From Baseline to 6 months | — |
| Changes in carbohydrate metabolism | Baseline to 6 months | Change in serum insulin |
| Changes in blood lipids | Baseline to 6 months | Change in serum triglycerides |
| Change in functional measurements | Baseline to 6 months | Change in cardiorespiratory fitness through graded exercise testing |
| Change in the index of fatty acid metabolism | Baseline to 6 months | Change in serum 3 hydroxybutyric acid |
Countries
United States
Outcome results
None listed