Fat Metabolism in Response to Acute Diet- and Exercise-induced Changes in Energy Balance
DEV
VLDL-triglyceride Metabolism in Response to Acute Diet- and Exercise-induced Changes in Energy Balance
1 other identifier
interventional
12
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable cardiovascular-diseases
Started Apr 2006
Longer than P75 for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 26, 2009
CompletedFirst Posted
Study publicly available on registry
January 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJanuary 21, 2013
January 1, 2013
6.7 years
January 26, 2009
January 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Very Low Density Lipoprotein-Triglyceride and apoB-100 concentrations
After acute (24 hour) changes in energy intake and/or energy expenditure
Secondary Outcomes (8)
Liver Very Low Density Lipoprotein-Triglyceride and apoB-100 secretion rates
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
After acute (24 hour) changes in energy intake and/or energy expenditure
Plasma glucose concentration and turnover rate
After acute (24 hour) changes in energy intake and/or energy expenditure
Plasma insulin concentration
After acute (24 hour) changes in energy intake and/or energy expenditure
Plasma free fatty acid concentration and turnover rate
After acute (24 hour) changes in energy intake and/or energy expenditure
- +3 more secondary outcomes
Study Arms (4)
Positive energy balance
EXPERIMENTALComparison between isocaloric and hypercaloric diets with no exercise performed in any trials
Energy balance with exercise
EXPERIMENTALComparison 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.
Negative energy balance
EXPERIMENTALComparison between isocaloric and hypocaloric diets with no exercise performed in any trials
Negative energy balance with exercise
EXPERIMENTALComparison 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- overweight and obese men
- normal to mild hypertriglyceridemia
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University in Saint Louis
St Louis, Missouri, 63110, United States
Related Publications (1)
Smith GI, Magkos F, Reeds DN, Okunade AL, Patterson BW, Mittendorfer B. One day of mixed meal overfeeding reduces hepatic insulin sensitivity and increases VLDL particle but not VLDL-triglyceride secretion in overweight and obese men. J Clin Endocrinol Metab. 2013 Aug;98(8):3454-62. doi: 10.1210/jc.2013-1786. Epub 2013 Jun 7.
PMID: 23750033DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bettina Mittendorfer, PhD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2009
First Posted
January 28, 2009
Study Start
April 1, 2006
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
January 21, 2013
Record last verified: 2013-01