Fat Metabolism in Response to Acute Diet- and Exercise-Induced Changes in Energy Balance - Full Text View

Sponsored by:	Washington University School of Medicine
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00830999

Purpose

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

Condition	Intervention
Cardiovascular Diseases	Behavioral: diet and exercise

MedlinePlus related topics: Diets Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Single Group Assignment
Official Title:	VLDL-Triglyceride Metabolism in Response to Acute Diet- and Exercise-Induced Changes in Energy Balance

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

Changes in Very Low Density Lipoprotein-Triglyceride concentration [ Time Frame: Measured over 48 hour periods on 3 separate occasions each with differing levels of energy intake and expenditure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Liver Very Low Density Lipoprotein-Triglyceride secretion rate [ Time Frame: Measured on 3 separate occasions the day following acute (24 hour) changes in energy intake and expenditure ] [ Designated as safety issue: No ]
Liver Very Low Density Lipoprotein-Triglyceride clearance from plasma [ Time Frame: Measured on 3 separate occasions the day following acute (24 hour) changes in energy intake and expenditure ] [ Designated as safety issue: No ]

Estimated Enrollment:	16
Study Start Date:	April 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Normal diet with no exercise: Experimental	Behavioral: diet and exercise You will be asked to perform 3 of the 5 study arms each on a seperate occasion. The order of the arms will be randomized. Each arm will last for 24 hours with fat metabolism also studied the following day (total stay at the research center will be approximately 49 hours on each occasion).
Normal diet plus exercise: Experimental	Behavioral: diet and exercise You will be asked to perform 3 of the 5 study arms each on a seperate occasion. The order of the arms will be randomized. Each arm will last for 24 hours with fat metabolism also studied the following day (total stay at the research center will be approximately 49 hours on each occasion).
high calorie diet plus exercise: Experimental	Behavioral: diet and exercise You will be asked to perform 3 of the 5 study arms each on a seperate occasion. The order of the arms will be randomized. Each arm will last for 24 hours with fat metabolism also studied the following day (total stay at the research center will be approximately 49 hours on each occasion).
high calorie diet with no exercise: Experimental	Behavioral: diet and exercise You will be asked to perform 3 of the 5 study arms each on a seperate occasion. The order of the arms will be randomized. Each arm will last for 24 hours with fat metabolism also studied the following day (total stay at the research center will be approximately 49 hours on each occasion).
low calorie diet with no exercise: Experimental	Behavioral: diet and exercise You will be asked to perform 3 of the 5 study arms each on a seperate occasion. The order of the arms will be randomized. Each arm will last for 24 hours with fat metabolism also studied the following day (total stay at the research center will be approximately 49 hours on each occasion).

Detailed 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.

Eligibility

Ages Eligible for Study:	21 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830999

Contacts

Contact: Gordon I Smith, PhD

314-362-4375

gsmith@dom.wustl.edu

Locations

United States, Missouri
Washington University in Saint Louis	Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Gordon I Smith, PhD 314-362-4375 gsmith@dom.wustl.edu

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

Bettina Mittendorfer, PhD

Washington University School of Medicine

More Information

No publications provided

Responsible Party:	WashingtonU ( Bettina Mittendorfer, PhD )
Study ID Numbers:	05-0195
Study First Received:	January 26, 2009
Last Updated:	January 26, 2009
ClinicalTrials.gov Identifier:	NCT00830999 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

fat metabolism
exercise
liver
lipoproteins
triglycerides

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 06, 2009