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Completed

NCT Number: NCT00830999

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

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.

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Key information

Conditions

Cardiovascular Diseases Behavior Motor Activity

Age range

21 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Washington University in Saint Louis

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Positive energy balance

Behavioral

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

Energy balance with exercise

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.

Negative energy balance

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.

Negative energy balance with exercise

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

Behavioral

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

Primary outcomes

  1. Very Low Density Lipoprotein-Triglyceride and apoB-100 concentrations

    Time frame: After acute (24 hour) changes in energy intake and/or energy expenditure

Secondary outcomes

  1. Liver Very Low Density Lipoprotein-Triglyceride and apoB-100 secretion rates

    Time frame: After acute (24 hour) changes in energy intake and/or energy expenditure

  2. Liver Very Low Density Lipoprotein-Triglyceride and apoB-100 clearance rates from plasma

    Time frame: After acute (24 hour) changes in energy intake and/or energy expenditure

  3. Plasma glucose concentration and turnover rate

    Time frame: After acute (24 hour) changes in energy intake and/or energy expenditure

  4. Plasma insulin concentration

    Time frame: After acute (24 hour) changes in energy intake and/or energy expenditure

  5. Plasma free fatty acid concentration and turnover rate

    Time frame: After acute (24 hour) changes in energy intake and/or energy expenditure

  6. Plasma glucose concentration

    Time frame: During acute (24 hour) changes in energy intake and/or energy expenditure

    Measured hourly over the 24 h period.

  7. Plasma insulin concentration

    Time frame: During acute (24 hour) changes in energy intake and/or energy expenditure

    Measured hourly over the 24 h period.

  8. Plasma free fatty acid concentration

    Time frame: During acute (24 hour) changes in energy intake and/or energy expenditure

    Measured hourly over the 24 h period.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Acronym: DEV

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Jan 28, 2009
Registry last updated
Jan 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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