The Energy Flux Study

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01736098
• Other study ID #: Pro00018017
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: August 2014

Study information

• Verified date: February 2023
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Physical Activity

Intervention

Other:
• Energy Flux Exercise Intervention
Comparison of high, medium and low energy flux groups with all groups matching energy intake and expenditure

Locations

Country	Name	City	State
United States	Public Health Research Center, University of South Carolina	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of South Carolina	The Coca-Cola Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in blood lipids	Change in serum triglycerides	Baseline to 6 months
Other	Changes in blood lipids	Change in High Density Lipoprotein [HDL]	Baseline to 6 months
Other	Changes in blood lipids	Change in Low Density Lipoprotein [LDL]	Baseline to 6 months
Other	Changes in blood lipids	Change in LDL particle size	Baseline to 6 months
Other	Change in functional measurements	Change in cardiorespiratory fitness through graded exercise testing	Baseline to 6 months
Other	Change in functional measurements	Change in resting metabolic rate	Baseline to 6 months
Other	Changes in markers of systemic inflammation	Change in tumor necrosis factor-alpha [TNF-alpha]	Baseline to 6 months
Other	Changes in markers of systemic inflammation	Change in C reactive protein [CRP]	Baseline to 6 months
Other	Changes in markers of systemic inflammation	Change in interleukin-6 [IL-6]	Baseline to 6 months
Other	Changes in triglyceride / cholesterol transport	Change in Apolipoprotein E [ApoE]	Baseline to 6 months
Other	Changes in triglyceride / cholesterol transport	Change in Apolipoprotein B-48 [ApoB-48]	Baseline to 6 months
Other	Changes in triglyceride / cholesterol transport	Change in Apolipoprotein B-100 [ApoB-100]	Baseline to 6 months
Other	Change in the index of fatty acid metabolism	Change in serum 3 hydroxybutyric acid	Baseline to 6 months
Other	Changes in carbohydrate metabolism	Change in serum insulin	Baseline to 6 months
Other	Changes in carbohydrate metabolism	Change in glucose	Baseline to 6 months
Other	Changes in carbohydrate metabolism	Change in hemoglobin A1c [HbA1c]	Baseline to 6 months
Other	Changes in energy intake		From Baseline to 6 months
Other	Changes in energy expenditure		From Baseline to 6 months
Primary	Changes in anthropometrics	Changes in lean and fat mass	From baseline to 6 months