Metabolic SyndromeNCT03872349
Effects of Monounsaturated Fatty Acids on Intestinal Lipid Metabolism in Insulin Resistant Subjects (MUFA )
A study testing Monounsaturated fatty acids diet and Saturated fatty acids diet in people with Metabolic Syndrome, run by Laval University at 1 site in Canada.
Trial summary
The overaccumulation of apolipoprotein (apo)B-48-containing lipoproteins of intestinal origin observed in patients with insulin-resistance is now thought to be attributable to both elevated intestinal production and reduced clearance of these lipoproteins. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Monounsaturated fatty acids diet and Saturated fatty acids diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 9 Feb 2020to 4 Oct 2024
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women aged between 18-60 years
- Waist circumference > 102 cm (men) and > 88 cm (women)
- HDL-cholesterol < 1.1 mmol/L (men) and < 1.3 mmol/L (women)
- Triglycerides > 1.7 mmol/L
- Fasting blood glucose > 6.1 mmol/L
- Normal blood pressure (<130/85)
Who cannot join
- Men and women < 18 or > 60 years
- Smokers (> 1 cigarette/day)
- Body weight variation > 10% during the last 6 months prior to the study baseline
- Subjects with a previous history of cardiovascular disease
- Subjects with type 2 diabetes
- Subjects with a monogenic dyslipidemia
Show all 10Show fewer
- Subjects on hypertension medications or medications known to affect lipoprotein metabolism or the integrity of gastrointestinal mucosa
- Subjects with endocrine or gastrointestinal disorders
- History of alcohol or drug abuse within the past 2 years
- Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institute of Nutrition and Functional Foods (INAF)
Québec, Quebec, G1V 0A6
About this study
Official title: Differential Effects of Saturated and Monounsaturated Fatty Acids on Chylomicron Secretion and Expression of Key Genes That Regulate Intestinal Lipid Metabolism in Insulin Resistant Subjects
The overaccumulation of apolipoprotein (apo)B-48-containing lipoproteins of intestinal origin observed in patients with insulin-resistance is now thought to be attributable to both elevated intestinal production and reduced clearance of these lipoproteins. Substantial evidence exists indicating that elevated plasma levels of these lipoproteins are associated with increased cardiovascular disease (CVD) risk. Therefore, reduction of atherogenic plasma triglyceride-rich lipoproteins à (TRL) levels of intestinal origin appears to be crucial to improve CVD risk associated with insulin-resistance. In this regard, there is some evidence that the clinical recommendation to replace dietary saturated fatty acids (SFAs) by monounsaturated fatty acids (MUFAs) reduces CVD risk in the general population. Although the beneficial impact of PUFAs on CVD risk has been related primarily to favorable changes in plasma LDL-cholesterol levels, recent data suggest that chronic MUFA consumption may also exert beneficial effects on CVD risk by reducing postprandial lipemia. The impact of substituting SFAs by MUFAs on postprandial lipid response may be of even greater significance in dyslipidemic patients with insulin-resistance among whom intestinal TRLs represent a large proportion of the atherogenic lipoproteins. The general objective of the proposed research is to investigate how dietary MUFAs in place of SFAs modify intestinal lipoprotein metabolism in men and women with dyslipidemia associated with insulin-resistance. The investigators hypothesize that the intestinal secretion of apoB-48-containing lipoproteins will be lower following a diet rich in MUFAs than after consuming a diet rich in SFAs. The investigators also hypothesize that substitution of SFAs by MUFAs will be associated with significant alterations in expression of key genes and proteins involved in intestinal lipoprotein metabolism.
- Conditions
- Metabolic Syndrome
- Being tested
- Monounsaturated fatty acids diet, Saturated fatty acids diet
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monounsaturated fatty acids dietOther
During 4 weeks, subjects eat a diet high in monounsaturated fatty acids and will have a duodenal gastroscopy and a kinetic study at the end of the 4-week period.
Saturated fatty acids dietOther
During 4 weeks, subjects eat a diet high in saturated fatty acids and will have a duodenal gastroscopy and a kinetic study at the end of the 4-week period.
| Study group | Role | What they receive |
|---|---|---|
| Monounsaturated fatty acids diet | Experimental | During 4 weeks, subjects eat a diet high in monounsaturated fatty acids (percent of total caloric intake: 15.0% from proteins; 50.0% from carbohydrates; 35.0% from fat: 7.1% from saturated fat; 20.7% from monounsaturated fat; 7.2% from n-6 polyunsaturated fat). Receives: Other: Monounsaturated fatty acids diet; Other: Saturated fatty acids diet |
| Saturated fatty acids diet | Experimental | During 4 weeks, subjects eat a diet high in polyunsaturated fatty acids (percent of total caloric intake: 15.0% from proteins; 50.0% from carbohydrates; 35.0% from fat: 13.4% from saturated fat; 14.4% from monounsaturated fat; 7.2% from n-6 polyunsaturated fat). Receives: Other: Monounsaturated fatty acids diet; Other: Saturated fatty acids diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TRL apolipoprotein B48 (apoB-48) production rate.
Measured: At week 4 and week 12 (at the end of the two 4-weeks diets)
Secondary outcomes (3)
Changes in duodenal expression of Niemann-Pick C1-like 1, Adenosine triphosphate-binding cassette transporters, Fatty Acid Binding Protein, Sterol Regulatory Element Binding Protein.
Measured: At week 4 and week 12 (at the end of the two 4-weeks diets)
Changes in duodenal expression of diacylglycerol acyltransferase, Acyl-CoA:cholesterol O-acyltransferase 2 and 3-hydroxy-methylglutaryl-CoA reductase.
Measured: At week 4 and week 12 (at the end of the two 4-weeks diets)
Change in synthesis of apoB-48 containing lipoproteins (Microsomal triglyceride transfer protein (MTP), apoB-48).
Measured: At week 4 and week 12 (at the end of the two 4-weeks diets)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start9 Feb 2020
- Primary completion19 Feb 2024
- Study completion4 Oct 2024
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 Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Patrick Couture, Laval University
- Investigators
- Patrick Couture, MD, FRCP, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872349
- Sponsor's protocol ID
- INAF-MUFA
- Status last verified
- Oct 2024
- First submitted
- 11 Mar 2019
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Desjardins LC, Briere F, Tremblay AJ, Rancourt-Bouchard M, Drouin-Chartier JP, Corbeil J, Lemelin V, Charest A, Schaefer EJ, Lamarche B, Couture P. Substitution of dietary monounsaturated fatty acids from olive oil for saturated fatty acids from lard increases low-density lipoprotein apolipoprotein B-100 fractional catabolic rate in subjects with dyslipidemia associated with insulin resistance: a randomized controlled trial. Am J Clin Nutr. 2024 May;119(5):1270-1279. doi: 10.1016/j.ajcnut.2024.03.015. Epub 2024 Mar 20.
PubMed 38518848
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Effects of Saturated and Monounsaturated Fatty Acids on Chylomicron Secretion and Expression of Key Genes That Regulate Intestinal Lipid Metabolism in Insulin Resistant Subjects
- ClinicalTrials.gov ID
- NCT03872349
- Acronym / sponsor ID
- INAF-MUFA
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 9 Feb 2020 (actual)
- Primary completion
- 19 Feb 2024 (actual)
- Study completion
- 4 Oct 2024 (actual)
- First posted
- 13 Mar 2019 (actual)
- 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 overaccumulation of apolipoprotein (apo)B-48-containing lipoproteins of intestinal origin observed in patients with insulin-resistance is now thought to be attributable to both elevated intestinal production and reduced clearance of these lipoproteins. Substantial evidence exists indicating that elevated plasma levels of these lipoproteins are associated with increased cardiovascular disease (CVD) risk. Therefore, reduction of atherogenic plasma triglyceride-rich lipoproteins à (TRL) levels of intestinal origin appears to be crucial to improve CVD risk associated with insulin-resistance. In this regard, there is some evidence that the clinical recommendation to replace dietary saturated fatty acids (SFAs) by monounsaturated fatty acids (MUFAs) reduces CVD risk in the general population. Although the beneficial impact of PUFAs on CVD risk has been related primarily to favorable changes in plasma LDL-cholesterol levels, recent data suggest that chronic MUFA consumption may also exert beneficial effects on CVD risk by reducing postprandial lipemia. The impact of substituting SFAs by MUFAs on postprandial lipid response may be of even greater significance in dyslipidemic patients with insulin-resistance among whom intestinal TRLs represent a large proportion of the atherogenic lipoproteins. The general objective of the proposed research is to investigate how dietary MUFAs in place of SFAs modify intestinal lipoprotein metabolism in men and women with dyslipidemia associated with insulin-resistance. The investigators hypothesize that the intestinal secretion of apoB-48-containing lipoproteins will be lower following a diet rich in MUFAs than after consuming a diet rich in SFAs. The investigators also hypothesize that substitution of SFAs by MUFAs will be associated with significant alterations in expression of key genes and proteins involved in intestinal lipoprotein metabolism.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monounsaturated fatty acids diet | Experimental | Other: Monounsaturated fatty acids diet, Other: Saturated fatty acids dietDuring 4 weeks, subjects eat a diet high in monounsaturated fatty acids (percent of total caloric intake: 15.0% from proteins; 50.0% from carbohydrates; 35.0% from fat: 7.1% from saturated fat; 20.7% from monounsaturated fat; 7.2% from n-6 polyunsaturated fat). |
| Saturated fatty acids diet | Experimental | Other: Monounsaturated fatty acids diet, Other: Saturated fatty acids dietDuring 4 weeks, subjects eat a diet high in polyunsaturated fatty acids (percent of total caloric intake: 15.0% from proteins; 50.0% from carbohydrates; 35.0% from fat: 13.4% from saturated fat; 14.4% from monounsaturated fat; 7.2% from n-6 polyunsaturated fat). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Men and women aged between 18-60 years
- Waist circumference > 102 cm (men) and > 88 cm (women)
- HDL-cholesterol < 1.1 mmol/L (men) and < 1.3 mmol/L (women)
- Triglycerides > 1.7 mmol/L
- Fasting blood glucose > 6.1 mmol/L
Key exclusion criteria (10 listed)
- Men and women < 18 or > 60 years
- Smokers (> 1 cigarette/day)
- Body weight variation > 10% during the last 6 months prior to the study baseline
- Subjects with a previous history of cardiovascular disease
- Subjects with type 2 diabetes
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 |
|---|---|---|
| Monounsaturated fatty acids dietDuring 4 weeks, subjects eat a diet high in monounsaturated fatty acids and will have a duodenal gastroscopy and a kinetic study at the end of the 4-week period. | Other | Monounsaturated fatty acids diet, Saturated fatty acids diet |
| Saturated fatty acids dietDuring 4 weeks, subjects eat a diet high in saturated fatty acids and will have a duodenal gastroscopy and a kinetic study at the end of the 4-week period. | Other | Monounsaturated fatty acids diet, Saturated fatty acids diet |
Primary outcome
Change in TRL apolipoprotein B48 (apoB-48) production rate.
Time frame: At week 4 and week 12 (at the end of the two 4-weeks diets)
3 secondary outcomes
Changes in duodenal expression of Niemann-Pick C1-like 1, Adenosine triphosphate-binding cassette transporters, Fatty Acid Binding Protein, Sterol Regulatory Element Binding Protein.
Time frame: At week 4 and week 12 (at the end of the two 4-weeks diets)
Changes in duodenal expression of diacylglycerol acyltransferase, Acyl-CoA:cholesterol O-acyltransferase 2 and 3-hydroxy-methylglutaryl-CoA reductase.
Time frame: At week 4 and week 12 (at the end of the two 4-weeks diets)
Change in synthesis of apoB-48 containing lipoproteins (Microsomal triglyceride transfer protein (MTP), apoB-48).
Time frame: At week 4 and week 12 (at the end of the two 4-weeks diets)
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 9 Oct 2024.
- Derived from this study: PubMed 38518848Desjardins LC, Briere F, Tremblay AJ, Rancourt-Bouchard M, Drouin-Chartier JP, Corbeil J, Lemelin V, Charest A, Schaefer EJ, Lamarche B, Couture P. Substitution of dietary monounsaturated fatty acids from olive oil for saturated fatty acids from lard increases low-density lipoprotein apolipoprotein B-100 fractional catabolic rate in subjects with dyslipidemia associated with insulin resistance: a randomized controlled trial. Am J Clin Nutr. 2024 May;119(5):1270-1279. doi: 10.1016/j.ajcnut.2024.03.015. Epub 2024 Mar 20.
- Individual participant dataSharing planned: No
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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.
Patrick Couture, MD, FRCP, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monounsaturated fatty acids diet and Saturated fatty acids diet in people with Metabolic Syndrome, run by Laval University at 1 site in Canada.
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 6 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 9 Oct 2024. 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 Canada. 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?
Change in TRL apolipoprotein B48 (apoB-48) production rate. (time frame: At week 4 and week 12 (at the end of the two 4-weeks diets)). 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 NCT03872349, 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 9 Oct 2024.