The Energy Flux Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Coca-Cola Company
Information provided by (Responsible Party):
University of South Carolina
ClinicalTrials.gov Identifier:
NCT01736098
First received: November 15, 2012
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

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?


Condition Intervention
Physical Activity
Other: Energy Flux Exercise Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Evaluation of Energy Balance at High vs. Low Energy Flux - Energy Flux Study

Resource links provided by NLM:


Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • Changes in anthropometrics [ Time Frame: From baseline to 6 months ] [ Designated as safety issue: No ]
    Changes in lean and fat mass


Other Outcome Measures:
  • Changes in blood lipids [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Change in serum triglycerides

  • Changes in blood lipids [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Change in High Density Lipoprotein [HDL]

  • Changes in blood lipids [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Change in Low Density Lipoprotein [LDL]

  • Changes in blood lipids [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Change in LDL particle size

  • Change in functional measurements [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Change in cardiorespiratory fitness through graded exercise testing

  • Change in functional measurements [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Change in resting metabolic rate

  • Changes in markers of systemic inflammation [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Change in tumor necrosis factor-alpha [TNF-alpha]

  • Changes in markers of systemic inflammation [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Change in C reactive protein [CRP]

  • Changes in markers of systemic inflammation [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Change in interleukin-6 [IL-6]

  • Changes in triglyceride / cholesterol transport [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Change in Apolipoprotein E [ApoE]

  • Changes in triglyceride / cholesterol transport [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Change in Apolipoprotein B-48 [ApoB-48]

  • Changes in triglyceride / cholesterol transport [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Change in Apolipoprotein B-100 [ApoB-100]

  • Change in the index of fatty acid metabolism [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Change in serum 3 hydroxybutyric acid

  • Changes in carbohydrate metabolism [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Change in serum insulin

  • Changes in carbohydrate metabolism [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Change in glucose

  • Changes in carbohydrate metabolism [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Change in hemoglobin A1c [HbA1c]

  • Changes in energy intake [ Time Frame: From Baseline to 6 months ] [ Designated as safety issue: No ]
  • Changes in energy expenditure [ Time Frame: From Baseline to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: August 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736098

Locations
United States, South Carolina
Public Health Research Center, University of South Carolina
Columbia, South Carolina, United States, 29201
Sponsors and Collaborators
University of South Carolina
The Coca-Cola Company
Investigators
Principal Investigator: Gregory Hand, Ph.D University of South Carolina
Principal Investigator: Steven Blair, Ph.D University of South Carolina
  More Information

No publications provided

Responsible Party: University of South Carolina
ClinicalTrials.gov Identifier: NCT01736098     History of Changes
Other Study ID Numbers: Energy Flux
Study First Received: November 15, 2012
Last Updated: November 15, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 20, 2014