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

Cardiovascular Diseases Clinical Trial

— DEV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00830999
• Other study ID #: 05-0195
• Status: Completed
• Phase: N/A
• First received: January 26, 2009
• Last updated: January 18, 2013
• Start date: April 2006
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• Positive energy balance
Subjects will consume over a 24 hour period 33% more calories than they require to meet their energy demands.
• 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.
• 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.
• 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
• Energy balance
Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.

Locations

Country	Name	City	State
United States	Washington University in Saint Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Very Low Density Lipoprotein-Triglyceride and apoB-100 concentrations		After acute (24 hour) changes in energy intake and/or energy expenditure	No
Secondary	Liver Very Low Density Lipoprotein-Triglyceride and apoB-100 secretion rates		After acute (24 hour) changes in energy intake and/or energy expenditure	No
Secondary	Liver Very Low Density Lipoprotein-Triglyceride and apoB-100 clearance rates from plasma		After acute (24 hour) changes in energy intake and/or energy expenditure	No
Secondary	Plasma glucose concentration and turnover rate		After acute (24 hour) changes in energy intake and/or energy expenditure	No
Secondary	Plasma insulin concentration		After acute (24 hour) changes in energy intake and/or energy expenditure	No
Secondary	Plasma free fatty acid concentration and turnover rate		After acute (24 hour) changes in energy intake and/or energy expenditure	No
Secondary	Plasma glucose concentration	Measured hourly over the 24 h period.	During acute (24 hour) changes in energy intake and/or energy expenditure	No
Secondary	Plasma insulin concentration	Measured hourly over the 24 h period.	During acute (24 hour) changes in energy intake and/or energy expenditure	No
Secondary	Plasma free fatty acid concentration	Measured hourly over the 24 h period.	During acute (24 hour) changes in energy intake and/or energy expenditure	No