The Energy Flux Study

Study Overview
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Brief Summary
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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?

Detailed Description
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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).

Official Title
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Evaluation of Energy Balance at High vs. Low Energy Flux - Energy Flux Study

Conditions
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Physical Activity

Intervention / Treatment
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* Other: Energy Flux Exercise Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Energy Flux<br>Energy Flux Exercise Intervention: 7kcal/kg/day at 5 days/week of energy expenditure and matching energy intake | Other: Energy Flux Exercise Intervention<br>* Comparison of high, medium and low energy flux groups with all groups matching energy intake and expenditure<br>|
| Experimental: Medium Energy Flux<br>Energy Flux Exercise Intervention: 3.5kcal/kg/day at 5 days/week of energy expenditure and matching energy intake | Other: Energy Flux Exercise Intervention<br>* Comparison of high, medium and low energy flux groups with all groups matching energy intake and expenditure<br>|
| No Intervention: Low Energy Flux<br>No Intervention: maintain normal lifestyle | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in anthropometrics | Changes in lean and fat mass | From baseline to 6 months |