The Energy Flux Study

NCT ID: NCT01736098

Last Updated: 2023-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-08-31

Brief Summary

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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

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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).

Conditions

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Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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High Energy Flux

Energy Flux Exercise Intervention: 7kcal/kg/day at 5 days/week of energy expenditure and matching energy intake

Group Type EXPERIMENTAL

Energy Flux Exercise Intervention

Intervention Type OTHER

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

Medium Energy Flux

Energy Flux Exercise Intervention: 3.5kcal/kg/day at 5 days/week of energy expenditure and matching energy intake

Group Type EXPERIMENTAL

Energy Flux Exercise Intervention

Intervention Type OTHER

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

Low Energy Flux

No Intervention: maintain normal lifestyle

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Energy Flux Exercise Intervention

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Coca-Cola Company

INDUSTRY

Sponsor Role collaborator

University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Sarah Schumacher

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gregory Hand, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

Steven Blair, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

Locations

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Public Health Research Center, University of South Carolina

Columbia, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00018017

Identifier Type: -

Identifier Source: org_study_id

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