Cardiovascular DiseasesDEVNCT00830999
Fat Metabolism in Response to Acute Diet- and Exercise-induced Changes in Energy Balance
A study testing Positive energy balance, Energy balance with exercise and Negative energy balance in people with Cardiovascular Diseases, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Positive energy balance, Energy balance with exercise and Negative energy balance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- overweight and obese men
- normal to mild hypertriglyceridemia
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in Saint Louis
St Louis, Missouri, 63110
About this study
Official title: VLDL-triglyceride Metabolism in Response to Acute Diet- and Exercise-induced Changes in Energy Balance
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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Positive energy balance, Energy balance with exercise, Negative energy balance, Negative energy balance with exercise, Energy balance
- Keywords
- fat metabolism, exercise, liver, lipoproteins, triglycerides
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive energy balanceBehavioural
Subjects will consume over a 24 hour period 33% more calories than they require to meet their energy demands.
Energy balance with exerciseBehavioural
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 balanceBehavioural
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 exerciseBehavioural
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 balanceBehavioural
Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.
| Study group | Role | What they receive |
|---|---|---|
| Positive energy balance | Experimental | Comparison between isocaloric and hypercaloric diets with no exercise performed in any trials Receives: Behavioral: Positive energy balance; Behavioral: Energy balance |
| Energy balance with exercise | Experimental | 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. Receives: Behavioral: Energy balance with exercise; Behavioral: Energy balance |
| Negative energy balance | Experimental | Comparison between isocaloric and hypocaloric diets with no exercise performed in any trials Receives: Behavioral: Negative energy balance; Behavioral: Energy balance |
| Negative energy balance with exercise | Experimental | 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. Receives: Behavioral: Negative energy balance with exercise; Behavioral: Energy balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Very Low Density Lipoprotein-Triglyceride and apoB-100 concentrations
Measured: 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
Measured: 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
Measured: After acute (24 hour) changes in energy intake and/or energy expenditure
Plasma glucose concentration and turnover rate
Measured: After acute (24 hour) changes in energy intake and/or energy expenditure
Plasma insulin concentration
Measured: After acute (24 hour) changes in energy intake and/or energy expenditure
Plasma free fatty acid concentration and turnover rate
Measured: After acute (24 hour) changes in energy intake and/or energy expenditure
Plasma glucose concentration
Measured hourly over the 24 h period.
Measured: During acute (24 hour) changes in energy intake and/or energy expenditure
Plasma insulin concentration
Measured hourly over the 24 h period.
Measured: During acute (24 hour) changes in energy intake and/or energy expenditure
Plasma free fatty acid concentration
Measured hourly over the 24 h period.
Measured: During acute (24 hour) changes in energy intake and/or energy expenditure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startApr 2006
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bettina Mittendorfer, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830999
- Sponsor's protocol ID
- 05-0195
- Acronym
- DEV
- Status last verified
- Jan 2013
- First submitted
- 26 Jan 2009
- Last updated
- 21 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23750033
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VLDL-triglyceride Metabolism in Response to Acute Diet- and Exercise-induced Changes in Energy Balance
- ClinicalTrials.gov ID
- NCT00830999
- Acronym / sponsor ID
- DEV / 05-0195
- Conditions
- Cardiovascular Diseases
- Keywords
- fat metabolism, exercise, liver, lipoproteins, triglycerides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Positive energy balance | Experimental | Behavioral: Positive energy balance, Behavioral: Energy balanceComparison between isocaloric and hypercaloric diets with no exercise performed in any trials |
| Energy balance with exercise | Experimental | Behavioral: Energy balance with exercise, Behavioral: Energy balanceComparison 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 | Experimental | Behavioral: Negative energy balance, Behavioral: Energy balanceComparison between isocaloric and hypocaloric diets with no exercise performed in any trials |
| Negative energy balance with exercise | Experimental | Behavioral: Negative energy balance with exercise, Behavioral: Energy balanceComparison 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. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- overweight and obese men
- normal to mild hypertriglyceridemia
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive energy balanceSubjects will consume over a 24 hour period 33% more calories than they require to meet their energy demands. | Behavioural | Positive energy balance |
| Energy balance with exerciseSubjects 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. | Behavioural | Energy balance with exercise |
| Negative energy balanceSubjects 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. | Behavioural | Negative energy balance |
| Negative energy balance with exerciseSubjects 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 | Behavioural | Negative energy balance with exercise |
| Energy balanceSubjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs. | Behavioural | Energy balance with exercise, Negative energy balance, Negative energy balance with exercise, Positive energy balance |
Primary outcome
Very Low Density Lipoprotein-Triglyceride and apoB-100 concentrations
Time frame: After acute (24 hour) changes in energy intake and/or energy expenditure
8 secondary outcomes
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
Time frame: During acute (24 hour) changes in energy intake and/or energy expenditure
Plasma insulin concentration
Time frame: During acute (24 hour) changes in energy intake and/or energy expenditure
Plasma free fatty acid concentration
Time frame: During acute (24 hour) changes in energy intake and/or energy expenditure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2013.
- Derived from this study: PubMed 23750033Smith 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bettina Mittendorfer, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive energy balance, Energy balance with exercise and Negative energy balance in people with Cardiovascular Diseases, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Very Low Density Lipoprotein-Triglyceride and apoB-100 concentrations (time frame: After acute (24 hour) changes in energy intake and/or energy expenditure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00830999, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2013.