Fat Metabolism in Response to Acute Diet- and Exercise-induced Changes in Energy Balance

NCT ID: NCT00830999

Last Updated: 2013-01-21

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2012-12-31

Brief Summary

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This study is being conducted to learn more about the role of diet and exercise in regulating plasma triglyceride (fat) metabolism. The investigators will examine the effect of acute (24 hour) changes in energy intake and expenditure on fat metabolism the following day.

Detailed Description

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Excess body fat and a sedentary lifestyle are associated with increased plasma triglyceride (TG) and apolipoprotein B-100 (apoB-100) concentrations, which are important risk factors for the development of cardiovascular disease.

Weight loss and endurance exercise improve plasma lipid and lipoprotein concentrations. However, the mechanisms responsible for this effect are largely unknown, and much uncertainty remains regarding the independent roles of dietary energy intake, exercise energy expenditure, and net energy balance in controlling plasma TG concentrations.

The main goal of this project, therefore, is to investigate the mechanisms by which acute alterations in energy balance, induced by diet and/or physical activity (endurance exercise), regulate very-low density lipoprotein (VLDL) metabolism.

Subjects will be asked to perform 3 separate trials. One of these will always be an "energy balance" trial that will act as the control trial for the other 2 trials they perform. Subjects will therefore be randomized to 2 different study arms.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Positive energy balance

Comparison between isocaloric and hypercaloric diets with no exercise performed in any trials

Group Type EXPERIMENTAL

Positive energy balance

Intervention Type BEHAVIORAL

Subjects will consume over a 24 hour period 33% more calories than they require to meet their energy demands.

Energy balance

Intervention Type BEHAVIORAL

Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.

Energy balance with exercise

Comparison between an isocaloric diet without exercise and a hypercaloric diet with a sufficient amount of exercise performed to match the excess calories consumed resulting in both trials being in net energy balance.

Group Type EXPERIMENTAL

Energy balance with exercise

Intervention Type BEHAVIORAL

Subjects will consume over a 24 hour period 33% more calories than they require to meet their energy demands but will perform 2 hours of exercise that will be sufficient to burn off the excess calories consumed resulting in subjects being in net energy balance.

Energy balance

Intervention Type BEHAVIORAL

Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.

Negative energy balance

Comparison between isocaloric and hypocaloric diets with no exercise performed in any trials

Group Type EXPERIMENTAL

Negative energy balance

Intervention Type BEHAVIORAL

Subjects will consume over a 24 h period only 66% of the calories required to meet their energy demands such that they will be in a net negative calorie balance in this trial.

Energy balance

Intervention Type BEHAVIORAL

Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.

Negative energy balance with exercise

Comparison between consuming an isocaloric diet without exercise and consuming the same amount of calories as in the isocaloric trial but with exercise performed resulting in net negative energy balance in the exercise trial.

Group Type EXPERIMENTAL

Negative energy balance with exercise

Intervention Type BEHAVIORAL

Subjects will consume over a 24 hour period the same amount of calories as ingested in the isocaloric trial but will also perform 2 hours of exercise that will be sufficient to burn off a third of the calories they consumed during this day resulting in subjects being in net negative energy balance in this trial

Energy balance

Intervention Type BEHAVIORAL

Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.

Interventions

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Positive energy balance

Subjects will consume over a 24 hour period 33% more calories than they require to meet their energy demands.

Intervention Type BEHAVIORAL

Energy balance with exercise

Subjects will consume over a 24 hour period 33% more calories than they require to meet their energy demands but will perform 2 hours of exercise that will be sufficient to burn off the excess calories consumed resulting in subjects being in net energy balance.

Intervention Type BEHAVIORAL

Negative energy balance

Subjects will consume over a 24 h period only 66% of the calories required to meet their energy demands such that they will be in a net negative calorie balance in this trial.

Intervention Type BEHAVIORAL

Negative energy balance with exercise

Subjects will consume over a 24 hour period the same amount of calories as ingested in the isocaloric trial but will also perform 2 hours of exercise that will be sufficient to burn off a third of the calories they consumed during this day resulting in subjects being in net negative energy balance in this trial

Intervention Type BEHAVIORAL

Energy balance

Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* overweight and obese men
* normal to mild hypertriglyceridemia

Exclusion Criteria

* Smoking
* Any medical condition other than increased body weight (e.g. diabetes, heart disease, etc.).
* Use of drugs known to affect lipid metabolism (e.g. statins, etc.).
* Regular exercise training.
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bettina Mittendorfer, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University in Saint Louis

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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Smith GI, Magkos F, Reeds DN, Okunade AL, Patterson BW, Mittendorfer B. One day of mixed meal overfeeding reduces hepatic insulin sensitivity and increases VLDL particle but not VLDL-triglyceride secretion in overweight and obese men. J Clin Endocrinol Metab. 2013 Aug;98(8):3454-62. doi: 10.1210/jc.2013-1786. Epub 2013 Jun 7.

Reference Type DERIVED
PMID: 23750033 (View on PubMed)

Other Identifiers

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05-0195

Identifier Type: -

Identifier Source: org_study_id

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