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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00830999
First received: January 26, 2009
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Behavioral: Positive energy balance
Behavioral: Energy balance with exercise
Behavioral: Negative energy balance
Behavioral: Negative energy balance with exercise
Behavioral: Energy balance

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: VLDL-triglyceride Metabolism in Response to Acute Diet- and Exercise-induced Changes in Energy Balance

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Very Low Density Lipoprotein-Triglyceride and apoB-100 concentrations [ Time Frame: After acute (24 hour) changes in energy intake and/or energy expenditure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Plasma glucose concentration and turnover rate [ Time Frame: After acute (24 hour) changes in energy intake and/or energy expenditure ] [ Designated as safety issue: No ]
  • Plasma insulin concentration [ Time Frame: After acute (24 hour) changes in energy intake and/or energy expenditure ] [ Designated as safety issue: No ]
  • Plasma free fatty acid concentration and turnover rate [ Time Frame: After acute (24 hour) changes in energy intake and/or energy expenditure ] [ Designated as safety issue: No ]
  • Plasma glucose concentration [ Time Frame: During acute (24 hour) changes in energy intake and/or energy expenditure ] [ Designated as safety issue: No ]
    Measured hourly over the 24 h period.

  • Plasma insulin concentration [ Time Frame: During acute (24 hour) changes in energy intake and/or energy expenditure ] [ Designated as safety issue: No ]
    Measured hourly over the 24 h period.

  • Plasma free fatty acid concentration [ Time Frame: During acute (24 hour) changes in energy intake and/or energy expenditure ] [ Designated as safety issue: No ]
    Measured hourly over the 24 h period.


Enrollment: 12
Study Start Date: April 2006
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Positive energy balance
Comparison between isocaloric and hypercaloric diets with no exercise performed in any trials
Behavioral: Positive energy balance
Subjects will consume over a 24 hour period 33% more calories than they require to meet their energy demands.
Behavioral: Energy balance
Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.
Experimental: Energy balance with exercise
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
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.
Behavioral: Energy balance
Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.
Experimental: Negative energy balance
Comparison between isocaloric and hypocaloric diets with no exercise performed in any trials
Behavioral: 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.
Behavioral: Energy balance
Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.
Experimental: Negative energy balance with exercise
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
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
Behavioral: Energy balance
Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.

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.

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Missouri
Washington University in Saint Louis
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Bettina Mittendorfer, PhD Washington University School of Medicine
  More Information

No publications provided by Washington University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00830999     History of Changes
Other Study ID Numbers: 05-0195
Study First Received: January 26, 2009
Last Updated: January 18, 2013
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 August 28, 2014