ObesityNCT00475774
Body Fat Distribution and Fat Metabolism
A study testing Long-chain (C18:2) and medium chain fatty acid (C8 and C10). in people with Obesity and Metabolic Disease, run by TNO at 1 site in Netherlands.
Trial summary
The primary purpose of the study is to examine the effect of body fat distribution on the physiological response to a dietary fat intervention. Physiological response will be evaluated as fatty acid kinetics (plasma and subcutaneous fat appearance). Read more about this study
- Who is it for?
- Ages 30 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Disease
- What is being tested?
- Long-chain (C18:2) and medium chain fatty acid (C8 and C10).
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2007to Sep 2007
- 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 30 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Males aged between 30 - 60 years at Day 01 of the study
- Body Mass Index (BMI) between 27-35 kg/m2
- Range in waist-hip ratio as high as possible (preferably <0.90 or >0.95)
- Regular Dutch eating habits and used to consume margarine;
- Non restrained eater
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- Voluntary participation
- Having given written informed consent
- Willing to comply with the study procedures
- Agree to be informed about chance findings of pathology found with the MRI
- Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
- Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.
Who cannot join
- Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
- Having a history of medical or surgical events that may significantly affect the study outcome
- Use of medication that may influence appetite, and/or sensory functioning
- Smoking
- Alcohol consumption (> 28 units/week)
- Contra-indication to MRI scanning
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- Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
- Reported slimming or medically prescribed diet
- Reported vegan, vegetarian or macrobiotic
- Recent blood donation (<1 month prior to the start of the study)
- Not willing to give up blood donation during the study
- Not having a general practitioner
- Not willing to accept information-transfer concerning participation in the study, or information regarding his health to and from his general practitioner.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Body Fat Distribution on the Physiological Response to a Dietary Fat Intervention
The primary purpose of the study is to examine the effect of body fat distribution on the physiological response to a dietary fat intervention. Physiological response will be evaluated as fatty acid kinetics (plasma and subcutaneous fat appearance).
Secondary objectives are targeted protein production (apoB and adiponectin). Examination of the effect of chain length of the dietary fatty acids on fat tissue characteristics and the effect of chain length on satiety, will be studied as well.
Read the detailed description
Rationale: The increased prevalence of obesity and the related risk for metabolic diseases have resulted in increased interest in prevention of obesity through life-style interventions. The site of fat storage (visceral or subcutaneous) is considered to be relevant in terms of risk for metabolic disorders. The type of fat consumed may determine storage in either fat storage site and hence be related to metabolic disorders. Long-chain fatty acids have been suggested to be preferentially targeted to subcutaneous fat, whereas medium chain fatty acids may preferably be targeted to the visceral fat depot.
Objective: The primary objective is to examine the effect of body fat distribution on the physiological response to a dietary fat intervention. Physiological response will be evaluated as fatty acid kinetics (plasma and subcutaneous fat appearance), targeted protein production (apoB and adiponectin) and satiety.
Study design: The study is designed as a randomized, double-blind, cross-over trial. Two treatments will be supplied for three weeks, with a wash-out period of at least 3 weeks in-between.
Study population: Twelve apparently healthy overweight/obese men (30-60 years of age) with a BMI of 27-35 kg.m-2 (6 upper body obese (high WHR) en 6 lower body obese (low WHR)).
Intervention: Three weeks intervention with a fat replacement containing long chain fatty acids and three weeks intervention with a fat replacement containing medium chain fatty acids. The margarines will replace the normally consumed margarine. Consumption will take place with breakfast, lunch and dinner.
Main study parameters/endpoints: On the last day of each treatment period subjects will come to TNO for evaluation of the effect of the dietary intervention on fat metabolism and fat tissue. This will be examined with stable isotope techniques and fat biopsies of subcutaneous fat. At baseline subjects will have a total body scan in the MRI to characterize body fat.
- Conditions
- Obesity, Metabolic Disease
- Being tested
- Long-chain (C18:2) and medium chain fatty acid (C8 and C10).
- Medical subject headings
- Obesity, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-chain (C18:2) and medium chain fatty acid (C8 and C10).Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
fatty acid kinetics (in plasma and subcutaneous fat)
Measured: 3 weeks
lipoprotein and adiponectin metabolism
Measured: 3 weeks
Secondary outcomes (2)
visual analogue scales to evaluate satiety
Measured: 3 weeks
body weight
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startMay 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TNO
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports
- Investigators
- Wilrike Pasman, PhD, Principal investigator, TNO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475774
- Sponsor's protocol ID
- P7261
- Status last verified
- Apr 2008
- First submitted
- 18 May 2007
- Last updated
- 7 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Body Fat Distribution on the Physiological Response to a Dietary Fat Intervention
- ClinicalTrials.gov ID
- NCT00475774
- Acronym / sponsor ID
- P7261
- Conditions
- Obesity, Metabolic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- TNOUniversity, hospital or other
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports
- Study start
- May 2007
- Study completion
- Sep 2007 (actual)
- First posted
- 21 May 2007 (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.
The primary purpose of the study is to examine the effect of body fat distribution on the physiological response to a dietary fat intervention. Physiological response will be evaluated as fatty acid kinetics (plasma and subcutaneous fat appearance).
Secondary objectives are targeted protein production (apoB and adiponectin). Examination of the effect of chain length of the dietary fatty acids on fat tissue characteristics and the effect of chain length on satiety, will be studied as well.
Detailed description
Rationale: The increased prevalence of obesity and the related risk for metabolic diseases have resulted in increased interest in prevention of obesity through life-style interventions. The site of fat storage (visceral or subcutaneous) is considered to be relevant in terms of risk for metabolic disorders. The type of fat consumed may determine storage in either fat storage site and hence be related to metabolic disorders. Long-chain fatty acids have been suggested to be preferentially targeted to subcutaneous fat, whereas medium chain fatty acids may preferably be targeted to the visceral fat depot.
Objective: The primary objective is to examine the effect of body fat distribution on the physiological response to a dietary fat intervention. Physiological response will be evaluated as fatty acid kinetics (plasma and subcutaneous fat appearance), targeted protein production (apoB and adiponectin) and satiety.
Study design: The study is designed as a randomized, double-blind, cross-over trial. Two treatments will be supplied for three weeks, with a wash-out period of at least 3 weeks in-between.
Study population: Twelve apparently healthy overweight/obese men (30-60 years of age) with a BMI of 27-35 kg.m-2 (6 upper body obese (high WHR) en 6 lower body obese (low WHR)).
Intervention: Three weeks intervention with a fat replacement containing long chain fatty acids and three weeks intervention with a fat replacement containing medium chain fatty acids. The margarines will replace the normally consumed margarine. Consumption will take place with breakfast, lunch and dinner.
Main study parameters/endpoints: On the last day of each treatment period subjects will come to TNO for evaluation of the effect of the dietary intervention on fat metabolism and fat tissue. This will be examined with stable isotope techniques and fat biopsies of subcutaneous fat. At baseline subjects will have a total body scan in the MRI to characterize body fat.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy
- Males aged between 30 - 60 years at Day 01 of the study
- Body Mass Index (BMI) between 27-35 kg/m2
- Range in waist-hip ratio as high as possible (preferably <0.90 or >0.95)
- Regular Dutch eating habits and used to consume margarine;
Key exclusion criteria (13 listed)
- Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
- Having a history of medical or surgical events that may significantly affect the study outcome
- Use of medication that may influence appetite, and/or sensory functioning
- Smoking
- Alcohol consumption (> 28 units/week)
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 |
|---|---|---|
| Long-chain (C18:2) and medium chain fatty acid (C8 and C10). | Behavioural | – |
Primary outcome
fatty acid kinetics (in plasma and subcutaneous fat)
Time frame: 3 weeks
lipoprotein and adiponectin metabolism
Time frame: 3 weeks
2 secondary outcomes
visual analogue scales to evaluate satiety
Time frame: 3 weeks
body weight
Time frame: 3 weeks
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 7 Apr 2008.
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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.
Wilrike Pasman, PhD principal investigator
TNO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long-chain (C18:2) and medium chain fatty acid (C8 and C10). in people with Obesity and Metabolic Disease, run by TNO at 1 site in Netherlands.
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 12 inclusion and 13 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 7 Apr 2008. 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 Netherlands. 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?
fatty acid kinetics (in plasma and subcutaneous fat) (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2008.