An interventional study of Positive energy balance and Energy balance with exercise in Cardiovascular Diseases, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to male participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-21.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Prevention
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.
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 12 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
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Exclusion Criteria:
Comparison between isocaloric and hypercaloric diets with no exercise performed in any trials
Behavioral: Positive energy balance · Behavioral: Energy balance
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.
Behavioral: Energy balance with exercise · Behavioral: Energy balance
Comparison between isocaloric and hypocaloric diets with no exercise performed in any trials
Behavioral: Negative energy balance · Behavioral: Energy balance
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.
Behavioral: Negative energy balance with exercise · Behavioral: Energy balance
Subjects will consume over a 24 hour period 33% more calories than they require to meet their energy demands.
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.
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.
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
Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.
Very Low Density Lipoprotein-Triglyceride and apoB-100 concentrations
Time frame: After acute (24 hour) changes in energy intake and/or energy expenditure
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
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
Plasma glucose concentration and turnover rate
Time frame: After acute (24 hour) changes in energy intake and/or energy expenditure
Plasma insulin concentration
Time frame: After acute (24 hour) changes in energy intake and/or energy expenditure
Plasma free fatty acid concentration and turnover rate
Time frame: After acute (24 hour) changes in energy intake and/or energy expenditure
Plasma glucose concentration
Measured hourly over the 24 h period.
Time frame: During acute (24 hour) changes in energy intake and/or energy expenditure
Plasma insulin concentration
Measured hourly over the 24 h period.
Time frame: During acute (24 hour) changes in energy intake and/or energy expenditure
Plasma free fatty acid concentration
Measured hourly over the 24 h period.
Time frame: During acute (24 hour) changes in energy intake and/or energy expenditure
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine