NCT01736098

Brief 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

November 15, 2012

Last Update Submit

February 8, 2023

Conditions

Physical Activity

Outcome Measures

Primary Outcomes (1)

  • Changes in anthropometrics

    Changes in lean and fat mass

    From baseline to 6 months

Other Outcomes (18)

  • Changes in blood lipids

    Baseline to 6 months

  • Changes in blood lipids

    Baseline to 6 months

  • Changes in blood lipids

    Baseline to 6 months

  • +15 more other outcomes

Study Arms (3)

High Energy Flux

EXPERIMENTAL

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

Other: Energy Flux Exercise Intervention

Medium Energy Flux

EXPERIMENTAL

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

Other: Energy Flux Exercise Intervention

Low Energy Flux

NO INTERVENTION

No Intervention: maintain normal lifestyle

Interventions

Energy Flux Exercise InterventionOTHER

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

High Energy FluxMedium Energy Flux

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \<35
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Health Research Center, University of South Carolina

Columbia, South Carolina, 29201, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Gregory Hand, Ph.D

    University of South Carolina

    PRINCIPAL INVESTIGATOR

  • Steven Blair, Ph.D

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 15, 2012

First Posted

November 29, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

February 13, 2023

Record last verified: 2023-02

Locations

US(1)