Clinical trial NCT01736098: The Energy Flux Study
Official title: Evaluation of Energy Balance at High vs. Low Energy Flux - Energy Flux Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: The Coca-Cola Company
First posted: 2012-11-29
Enrollment: 81
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in anthropometrics
timeFrame: From baseline to 6 months
Secondary outcomes:
Other outcomes:
measure: Changes in blood lipids
timeFrame: Baseline to 6 months
measure: Changes in blood lipids
timeFrame: Baseline to 6 months
measure: Changes in blood lipids
timeFrame: Baseline to 6 months
measure: Changes in blood lipids
timeFrame: Baseline to 6 months
measure: Change in functional measurements
timeFrame: Baseline to 6 months
measure: Change in functional measurements
timeFrame: Baseline to 6 months
measure: Changes in markers of systemic inflammation
timeFrame: Baseline to 6 months
measure: Changes in markers of systemic inflammation
timeFrame: Baseline to 6 months
measure: Changes in markers of systemic inflammation
timeFrame: Baseline to 6 months
measure: Changes in triglyceride / cholesterol transport
timeFrame: Baseline to 6 months
measure: Changes in triglyceride / cholesterol transport
timeFrame: Baseline to 6 months
measure: Changes in triglyceride / cholesterol transport
timeFrame: Baseline to 6 months
measure: Change in the index of fatty acid metabolism
timeFrame: Baseline to 6 months
measure: Changes in carbohydrate metabolism
timeFrame: Baseline to 6 months
measure: Changes in carbohydrate metabolism
timeFrame: Baseline to 6 months
measure: Changes in carbohydrate metabolism
timeFrame: Baseline to 6 months
measure: Changes in energy intake
timeFrame: From Baseline to 6 months
measure: Changes in energy expenditure
timeFrame: From Baseline to 6 months
Locations:
city: Columbia
country: United States
facility: Public Health Research Center, University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Gregory Hand, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Carolina
name: Steven Blair, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: