The Energy Flux Study

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

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?

Study Overview

• Status: Completed
• Conditions: Physical Activity
• Intervention / Treatment: Other: Energy Flux Exercise Intervention

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).

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Public Health Research Center, University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	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]	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

Collaborators and Investigators

• Sponsor: University of South Carolina
• Collaborators: The Coca-Cola Company
• Investigators: Principal Investigator: Steven Blair, Ph.D, University of South Carolina; Principal Investigator: Gregory Hand, Ph.D, University of South Carolina

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: November 15, 2012
• First Submitted That Met QC Criteria: November 21, 2012
• First Posted (ESTIMATE): November 29, 2012

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Pro00018017