ObesityNCT01466816
Lipids and Insulin Sensitivity
A study testing test meals with various fatty acid compositions in people with Obesity and Insulin Resistance, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: The investigators hypothesize that a change in dietary fat quality (an increase in unsaturated fatty acids) may modulate fuel partitioning within the type 2 diabetic muscle towards less accumulation of lipid metabolites and an improved insulin sensitivity. Objective: 1. Read more about this study
- Who is it for?
- Ages 35 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance
- What is being tested?
- test meals with various fatty acid compositions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2008to Aug 2011
- 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 35 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obese males aged between 35 and 70 years with insulin resistance.
Who cannot join
- History of type 2 diabetes.
- Liver or kidney failure.
- Diseases in which the live expectation is shorter then 5 years.
- The use of experimental medication.
- Diseases/medication use that may have an influence on the glucose tolerance.
- Not to be able to understand the study information.
Show all 10Show fewer
- Users of fatty acid supplements including fish oils etc.
- Users of high doses of antioxidant vitamins.
- Athletes.
- People on a diet of people that are planning to lose weight.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre +
Maastricht, Limburg, 6229ER
About this study
Official title: Skeletal Muscle Lipid Metabolism and Insulin Sensitivity: Can Dietary Fatty Acid Composition Modulate Muscle Lipid Storage?
Rationale: The investigators hypothesize that a change in dietary fat quality (an increase in unsaturated fatty acids) may modulate fuel partitioning within the type 2 diabetic muscle towards less accumulation of lipid metabolites and an improved insulin sensitivity.
Objective:
Read more
- The contribution of dietary vs endogenous fat sources to lipid overflow in the circulation and to skeletal muscle lipid uptake and storage in obese insulin resistant subjects vs obese insulin sensitive controls.
- The acute effect of meals with various fatty acid composition ((high saturated (SFA) vs polyunsaturated (PUFA) vs monounsaturated (MUFA)) on skeletal muscle lipid uptake and storage, fatty acid mediated gene expression and postprandial insulin sensitivity in obese insulin resistant subjects.
Study design: single-blind randomized cross-over trial
Study population: obese males (35-70 years) with or without insulin resistance
Intervention:
- 1 test meal
- 3 test meals with a different fatty acid composition
Main study parameters/endpoints:
More insight whether dietary fat quality may modulate circulating lipids and skeletal muscle fatty acids handling, and may affect oxidative capacity and lipid storage in parallel to an increased insulin sensitivity.
- Conditions
- Obesity, Insulin Resistance
- Being tested
- test meals with various fatty acid compositions
- Keywords
- Lipid metabolism
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test meals with various fatty acid compositionsDietary supplement
Three different milkshakes with a U13C palmitate tracer added
| Study group | Role | What they receive |
|---|---|---|
| Saturated fatty acid test meal | Experimental | Not described Receives: Dietary Supplement: test meals with various fatty acid compositions |
| Monounsaturated fatty acid meal | Experimental | Not described Receives: Dietary Supplement: test meals with various fatty acid compositions |
| Polyunsaturated fatty acid meal | Experimental | Not described Receives: Dietary Supplement: test meals with various fatty acid compositions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute effect of meals with various fatty acid composition on postprandial insulin sensitivity
The acute effect of meals with various fatty acid composition ((high saturated (SFA) vs polyunsaturated (PUFA) vs monounsaturated (MUFA)) on postprandial insulin sensitivity will be measured during the stable isotope test.
Measured: the individual participants will be measured within 8-10 weeks.
Acute effect of meals with various fatty acid composition on forearm muscle fatty acid handling
Using the stable isotope technique, we can differentiate between the metabolic fate of dietary versus endogenous fatty acids
Measured: the individual participants will be measured within 8-10 weeks.
Secondary outcomes (2)
Acute effect of meals with various fatty acid composition on intramuscular fatty acid handling
Measured: the individual participants will be measured within 8-10 weeks.
Acute effect of meals with various fatty acid composition on transcriptional regulation of the fatty acid metabolism in skeletal muscle biopsies
Transcriptional regulation will be measured by means of microarray.
Measured: the individual participants will be measured within 8-10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startOct 2008
- Primary completionAug 2010
- Study completionAug 2011
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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen E Blaak, PhD, Prof, Principal investigator, Maastricht University Medical Centre +
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466816
- Sponsor's protocol ID
- 08-3-030
- Status last verified
- Nov 2011
- First submitted
- 19 Oct 2011
- Last updated
- 8 Nov 2011
- Results posted
- No
Publications
Jans A, Konings E, Goossens GH, Bouwman FG, Moors CC, Boekschoten MV, Afman LA, Muller M, Mariman EC, Blaak EE. PUFAs acutely affect triacylglycerol-derived skeletal muscle fatty acid uptake and increase postprandial insulin sensitivity. Am J Clin Nutr. 2012 Apr;95(4):825-36. doi: 10.3945/ajcn.111.028787. Epub 2012 Feb 15.
PubMed 22338035
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Muscle Lipid Metabolism and Insulin Sensitivity: Can Dietary Fatty Acid Composition Modulate Muscle Lipid Storage?
- ClinicalTrials.gov ID
- NCT01466816
- Acronym / sponsor ID
- 08-3-030
- Conditions
- Obesity, Insulin Resistance
- Keywords
- Lipid metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 8 Nov 2011 (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.
Rationale: The investigators hypothesize that a change in dietary fat quality (an increase in unsaturated fatty acids) may modulate fuel partitioning within the type 2 diabetic muscle towards less accumulation of lipid metabolites and an improved insulin sensitivity.
Objective:
- The contribution of dietary vs endogenous fat sources to lipid overflow in the circulation and to skeletal muscle lipid uptake and storage in obese insulin resistant subjects vs obese insulin sensitive controls.
- The acute effect of meals with various fatty acid composition ((high saturated (SFA) vs polyunsaturated (PUFA) vs monounsaturated (MUFA)) on skeletal muscle lipid uptake and storage, fatty acid mediated gene expression and postprandial insulin sensitivity in obese insulin resistant subjects.
Study design: single-blind randomized cross-over trial
Study population: obese males (35-70 years) with or without insulin resistance
Intervention:
- 1 test meal
- 3 test meals with a different fatty acid composition
Main study parameters/endpoints:
More insight whether dietary fat quality may modulate circulating lipids and skeletal muscle fatty acids handling, and may affect oxidative capacity and lipid storage in parallel to an increased insulin sensitivity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saturated fatty acid test meal | Experimental | Dietary Supplement: test meals with various fatty acid compositions |
| Monounsaturated fatty acid meal | Experimental | Dietary Supplement: test meals with various fatty acid compositions |
| Polyunsaturated fatty acid meal | Experimental | Dietary Supplement: test meals with various fatty acid compositions |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obese males aged between 35 and 70 years with insulin resistance.
Key exclusion criteria (10 listed)
- History of type 2 diabetes.
- Liver or kidney failure.
- Diseases in which the live expectation is shorter then 5 years.
- The use of experimental medication.
- Diseases/medication use that may have an influence on the glucose tolerance.
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 |
|---|---|---|
| test meals with various fatty acid compositionsThree different milkshakes with a U13C palmitate tracer added | Dietary supplement | Monounsaturated fatty acid meal, Polyunsaturated fatty acid meal, Saturated fatty acid test meal |
Primary outcome
Acute effect of meals with various fatty acid composition on postprandial insulin sensitivity
Time frame: the individual participants will be measured within 8-10 weeks.
The acute effect of meals with various fatty acid composition ((high saturated (SFA) vs polyunsaturated (PUFA) vs monounsaturated (MUFA)) on postprandial insulin sensitivity will be measured during the stable isotope test.
Acute effect of meals with various fatty acid composition on forearm muscle fatty acid handling
Time frame: the individual participants will be measured within 8-10 weeks.
Using the stable isotope technique, we can differentiate between the metabolic fate of dietary versus endogenous fatty acids
2 secondary outcomes
Acute effect of meals with various fatty acid composition on intramuscular fatty acid handling
Time frame: the individual participants will be measured within 8-10 weeks.
Acute effect of meals with various fatty acid composition on transcriptional regulation of the fatty acid metabolism in skeletal muscle biopsies
Time frame: the individual participants will be measured within 8-10 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 8 Nov 2011.
- Derived from this study: PubMed 22338035Jans A, Konings E, Goossens GH, Bouwman FG, Moors CC, Boekschoten MV, Afman LA, Muller M, Mariman EC, Blaak EE. PUFAs acutely affect triacylglycerol-derived skeletal muscle fatty acid uptake and increase postprandial insulin sensitivity. Am J Clin Nutr. 2012 Apr;95(4):825-36. doi: 10.3945/ajcn.111.028787. Epub 2012 Feb 15.
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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.
Ellen E Blaak, PhD, Prof principal investigator
Maastricht University Medical Centre +
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing test meals with various fatty acid compositions in people with Obesity and Insulin Resistance, run by Maastricht University Medical Center 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 1 inclusion and 10 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 8 Nov 2011. 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?
Acute effect of meals with various fatty acid composition on postprandial insulin sensitivity (time frame: the individual participants will be measured within 8-10 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?
On the ClinicalTrials.gov record for NCT01466816, 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 8 Nov 2011.