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

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The Washington University

Status

Completed

Conditions

Cardiovascular Diseases

Treatments

Behavioral: Positive energy balance
Behavioral: Negative energy balance with exercise
Behavioral: Energy balance with exercise
Behavioral: Negative energy balance
Behavioral: Energy balance

Study type

Interventional

Funder types

Other

Identifiers

NCT00830999
05-0195

Details and patient eligibility

About

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.

Full description

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.

Enrollment

12 patients

Sex

Male

Ages

21 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 4 patient groups

Positive energy balance
Experimental group
Description:
Comparison between isocaloric and hypercaloric diets with no exercise performed in any trials
Treatment:
Behavioral: Positive energy balance
Behavioral: Energy balance
Energy balance with exercise
Experimental group
Description:
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.
Treatment:
Behavioral: Energy balance with exercise
Behavioral: Energy balance
Negative energy balance
Experimental group
Description:
Comparison between isocaloric and hypocaloric diets with no exercise performed in any trials
Treatment:
Behavioral: Energy balance
Behavioral: Negative energy balance
Negative energy balance with exercise
Experimental group
Description:
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.
Treatment:
Behavioral: Negative energy balance with exercise
Behavioral: Energy balance

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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