Skip to main content
OpenTrials
Completed

NCT Number: NCT01736098

The 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?

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Public Health Research Center, University of South Carolina

Columbia, South Carolina, 29201, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Energy Flux Exercise Intervention

Other

Comparison of high, medium and low energy flux groups with all groups matching energy intake and expenditure

Primary outcomes

  1. Changes in anthropometrics

    Time frame: From baseline to 6 months

    Changes in lean and fat mass

Other outcomes

  1. Changes in blood lipids

    Time frame: Baseline to 6 months

    Change in serum triglycerides

  2. Changes in blood lipids

    Time frame: Baseline to 6 months

    Change in High Density Lipoprotein [HDL]

  3. Changes in blood lipids

    Time frame: Baseline to 6 months

    Change in Low Density Lipoprotein [LDL]

  4. Changes in blood lipids

    Time frame: Baseline to 6 months

    Change in LDL particle size

  5. Change in functional measurements

    Time frame: Baseline to 6 months

    Change in cardiorespiratory fitness through graded exercise testing

  6. Change in functional measurements

    Time frame: Baseline to 6 months

    Change in resting metabolic rate

  7. Changes in markers of systemic inflammation

    Time frame: Baseline to 6 months

    Change in tumor necrosis factor-alpha [TNF-alpha]

  8. Changes in markers of systemic inflammation

    Time frame: Baseline to 6 months

    Change in C reactive protein [CRP]

  9. Changes in markers of systemic inflammation

    Time frame: Baseline to 6 months

    Change in interleukin-6 [IL-6]

  10. Changes in triglyceride / cholesterol transport

    Time frame: Baseline to 6 months

    Change in Apolipoprotein E [ApoE]

  11. Changes in triglyceride / cholesterol transport

    Time frame: Baseline to 6 months

    Change in Apolipoprotein B-48 [ApoB-48]

  12. Changes in triglyceride / cholesterol transport

    Time frame: Baseline to 6 months

    Change in Apolipoprotein B-100 [ApoB-100]

  13. Change in the index of fatty acid metabolism

    Time frame: Baseline to 6 months

    Change in serum 3 hydroxybutyric acid

  14. Changes in carbohydrate metabolism

    Time frame: Baseline to 6 months

    Change in serum insulin

  15. Changes in carbohydrate metabolism

    Time frame: Baseline to 6 months

    Change in glucose

  16. Changes in carbohydrate metabolism

    Time frame: Baseline to 6 months

    Change in hemoglobin A1c [HbA1c]

  17. Changes in energy intake

    Time frame: From Baseline to 6 months

  18. Changes in energy expenditure

    Time frame: From Baseline to 6 months

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • The Coca-Cola Company

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 29, 2012
Registry last updated
Feb 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.