Cardiovascular DiseaseMedDietNCT00988650
Mediterranean Diet and the Metabolic Syndrome
A study testing isocaloric diet and free living conditions in people with Cardiovascular Disease, run by Laval University at 1 site in Canada.
Trial summary
While there is now undisputable evidence relating elevated plasma low-density lipoprotein (LDL) cholesterol levels to an increased risk of coronary heart disease (CHD), it is being increasingly recognized that a significant proportion of CHD events occur in individuals characterized by a cluster of additional… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- isocaloric diet and free living conditions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- May 2007to Dec 2008
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men from the Québec City metropolitan area with the metabolic syndrome based on the NCEP-ATP III definition (3 criteria or more see below):
- Waist circumference ≥ 102 cm
- Triglycerides ≥ 1.7 mmol/L
- HDL-cholesterol <= 1.04 mmol/L
- Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg
- Fasting blood glucose ≥ 5.6 mmol/L
- Stable body weight (+/- 2 kg) for 6 months before the beginning of the study
Who cannot join
- Previous history of cardiovascular disease, type 2 diabetes and monogenic dyslipidemia
- Subjects taking medications for hyperlipidemia or hypertension
- Endocrine disorders
- Food allergies or aversion for specific components of the MedDiet
- Smokers
- Consummation excessive of alcohol (> 2 consummation/day)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institute of Nutraceutical and Functional Foods (INAF), Laval University
Québec, Quebec, G1V 0A6
About this study
Official title: Mechanistic Investigation of the Mediterranean Diet and Its Impact on the Metabolic Syndrome in Men
While there is now undisputable evidence relating elevated plasma low-density lipoprotein (LDL) cholesterol levels to an increased risk of coronary heart disease (CHD), it is being increasingly recognized that a significant proportion of CHD events occur in individuals characterized by a cluster of additional metabolic and physiological perturbations now defined as the metabolic syndrome. Epidemiological and clinical evidence have shown us that nutritional factors, often in conjunction with obesity, play a pivotal role in the pathophysiology of the metabolic syndrome. In that regard, accumulating evidence suggest that a Mediterranean-style diet (MedDiet) may beneficially modify several components of the metabolic syndrome including plasma triglycerides (TG) and high-density lipoprotein (HDL) cholesterol levels, insulin resistance, waist circumference and markers of vascular inflammation. However, the physiological mechanisms underlying the cardioprotective effects of the MedDiet on features of the metabolic syndrome and the importance of body weight reduction in maximizing these effects represent key issues that have yet to be investigated.
The general objective of the study is to investigate for the first time in a controlled feeding study the mechanisms and factors underlying the impact of the MedDiet, with and without weight loss on the dyslipidemic features of the metabolic syndrome.
Read the detailed description
The study has a duration of 35 weeks for each participant. Subjects will be first assigned to a North American control diet that they will consume for five weeks under isocaloric, weight-maintaining conditions. Participants will then consume the MedDiet for 5 weeks, again under isocaloric, weight-maintaining conditions. All foods will be provided to participants during these consecutive 5-week diets. Participants subsequently will then undergo a 20-week weight loss period in free-living conditions during which they will be given advice on how to create a 500 kcal deficit in their daily energy intake. The last phase of the study consists of a second 5-week MedDiet consumed under feeding, weight stabilizing conditions. Metabolic studies and CHD risk factor assessment will be performed at the end of each experimental diets. Metabolic studies include the measurement of in vivo kinetics of apolipoprotein (apo)B-containing lipoproteins including small dense LDL, apoCIII, HDL (apoAI) and C-reactive protein (CRP) as well as indirect measures of cholesterol absorption and synthesis.
- Conditions
- Cardiovascular Disease
- Being tested
- isocaloric diet, free living conditions
- Keywords
- Metabolic syndrome, Mediterranean diet, Blood lipids, Coronary heart disease, Apolipoprotein
- Medical subject headings
- Cardiovascular Diseases, Metabolic Syndrome, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isocaloric dietOther
Also called 3 isocaloric die
free living conditionsOther
Also called weight lost free living conditions
| Study group | Role | What they receive |
|---|---|---|
| North American diet | Active comparator | Control North American diet for five weeks in isocaloric conditions Receives: Other: isocaloric diet |
| Mediterranean diet | Experimental | Mediterranean diet for five weeks in isocaloric conditions Receives: Other: isocaloric diet |
| weight loss period | Experimental | Weight loss period of 20-week (minimum 5% reduction in body weight) Receives: Other: free living conditions |
| Weight stabilizing mediterranean diet | Active comparator | Mediterranean diet for five weeks in isocaloric weight stabilizing conditions Receives: Other: isocaloric diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma LDL, TG and HDL-C
Measured: Week 5, 10 and 35 (at the end of each weight-maintaining diet)
Secondary outcomes (1)
CRP, and blood pressure, kinetic of lipoproteins
Measured: Week 5, 10 and 35 (at the end of each weight-maintaining diet)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startMay 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 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, Benoit Lamarche, Laval University
- Investigators
- Benoît Lamarche, PhD, Study director, Institute of Nutraceutical and Functional Foods (INAF), Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988650
- Sponsor's protocol ID
- INAF-2006-277
- Acronym
- MedDiet
- Status last verified
- Mar 2013
- First submitted
- 25 Sep 2009
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Richard C, Couture P, Desroches S, Nehme B, Bourassa S, Droit A, Lamarche B. Effect of an isoenergetic traditional Mediterranean diet on the high-density lipoprotein proteome in men with the metabolic syndrome. J Nutrigenet Nutrigenomics. 2014;7(1):48-60. doi: 10.1159/000363137. Epub 2014 Jul 4.
PubMed 25011605Richard C, Couture P, Desroches S, Lichtenstein AH, Lamarche B. Effect of an isoenergetic traditional Mediterranean diet on apolipoprotein A-I kinetic in men with metabolic syndrome. Nutr J. 2013 Jun 7;12(1):76. doi: 10.1186/1475-2891-12-76.
PubMed 24499022Richard C, Couture P, Ooi EM, Tremblay AJ, Desroches S, Charest A, Lichtenstein AH, Lamarche B. Effect of Mediterranean diet with and without weight loss on apolipoprotein B100 metabolism in men with metabolic syndrome. Arterioscler Thromb Vasc Biol. 2014 Feb;34(2):433-8. doi: 10.1161/ATVBAHA.113.302185. Epub 2013 Nov 21.
PubMed 24265415Richard C, Couture P, Desroches S, Lamarche B. Effect of the Mediterranean diet with and without weight loss on markers of inflammation in men with metabolic syndrome. Obesity (Silver Spring). 2013 Jan;21(1):51-7. doi: 10.1002/oby.20239.
PubMed 23505168
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Investigation of the Mediterranean Diet and Its Impact on the Metabolic Syndrome in Men
- ClinicalTrials.gov ID
- NCT00988650
- Acronym / sponsor ID
- MedDiet / INAF-2006-277
- Conditions
- Cardiovascular Disease
- Keywords
- Metabolic syndrome, Mediterranean diet, Blood lipids, Coronary heart disease, Apolipoprotein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- May 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 2 Oct 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.
While there is now undisputable evidence relating elevated plasma low-density lipoprotein (LDL) cholesterol levels to an increased risk of coronary heart disease (CHD), it is being increasingly recognized that a significant proportion of CHD events occur in individuals characterized by a cluster of additional metabolic and physiological perturbations now defined as the metabolic syndrome. Epidemiological and clinical evidence have shown us that nutritional factors, often in conjunction with obesity, play a pivotal role in the pathophysiology of the metabolic syndrome. In that regard, accumulating evidence suggest that a Mediterranean-style diet (MedDiet) may beneficially modify several components of the metabolic syndrome including plasma triglycerides (TG) and high-density lipoprotein (HDL) cholesterol levels, insulin resistance, waist circumference and markers of vascular inflammation. However, the physiological mechanisms underlying the cardioprotective effects of the MedDiet on features of the metabolic syndrome and the importance of body weight reduction in maximizing these effects represent key issues that have yet to be investigated.
The general objective of the study is to investigate for the first time in a controlled feeding study the mechanisms and factors underlying the impact of the MedDiet, with and without weight loss on the dyslipidemic features of the metabolic syndrome.
Detailed description
The study has a duration of 35 weeks for each participant. Subjects will be first assigned to a North American control diet that they will consume for five weeks under isocaloric, weight-maintaining conditions. Participants will then consume the MedDiet for 5 weeks, again under isocaloric, weight-maintaining conditions. All foods will be provided to participants during these consecutive 5-week diets. Participants subsequently will then undergo a 20-week weight loss period in free-living conditions during which they will be given advice on how to create a 500 kcal deficit in their daily energy intake. The last phase of the study consists of a second 5-week MedDiet consumed under feeding, weight stabilizing conditions. Metabolic studies and CHD risk factor assessment will be performed at the end of each experimental diets. Metabolic studies include the measurement of in vivo kinetics of apolipoprotein (apo)B-containing lipoproteins including small dense LDL, apoCIII, HDL (apoAI) and C-reactive protein (CRP) as well as indirect measures of cholesterol absorption and synthesis.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| North American diet | Active comparator | Other: isocaloric dietControl North American diet for five weeks in isocaloric conditions |
| Mediterranean diet | Experimental | Other: isocaloric dietMediterranean diet for five weeks in isocaloric conditions |
| weight loss period | Experimental | Other: free living conditionsWeight loss period of 20-week (minimum 5% reduction in body weight) |
| Weight stabilizing mediterranean diet | Active comparator | Other: isocaloric dietMediterranean diet for five weeks in isocaloric weight stabilizing conditions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men from the Québec City metropolitan area with the metabolic syndrome based on the NCEP-ATP III definition (3 criteria or more see below):
- Waist circumference ≥ 102 cm
- Triglycerides ≥ 1.7 mmol/L
- HDL-cholesterol <= 1.04 mmol/L
- Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg
Key exclusion criteria (6 listed)
- Previous history of cardiovascular disease, type 2 diabetes and monogenic dyslipidemia
- Subjects taking medications for hyperlipidemia or hypertension
- Endocrine disorders
- Food allergies or aversion for specific components of the MedDiet
- Smokers
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 |
|---|---|---|
| isocaloric dietAlso: 3 isocaloric die | Other | Mediterranean diet, North American diet, Weight stabilizing mediterranean diet |
| free living conditionsAlso: weight lost free living conditions | Other | weight loss period |
Primary outcome
plasma LDL, TG and HDL-C
Time frame: Week 5, 10 and 35 (at the end of each weight-maintaining diet)
1 secondary outcome
CRP, and blood pressure, kinetic of lipoproteins
Time frame: Week 5, 10 and 35 (at the end of each weight-maintaining diet)
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 5 Mar 2013.
- Derived from this study: PubMed 25011605Richard C, Couture P, Desroches S, Nehme B, Bourassa S, Droit A, Lamarche B. Effect of an isoenergetic traditional Mediterranean diet on the high-density lipoprotein proteome in men with the metabolic syndrome. J Nutrigenet Nutrigenomics. 2014;7(1):48-60. doi: 10.1159/000363137. Epub 2014 Jul 4.
- Derived from this study: PubMed 24499022Richard C, Couture P, Desroches S, Lichtenstein AH, Lamarche B. Effect of an isoenergetic traditional Mediterranean diet on apolipoprotein A-I kinetic in men with metabolic syndrome. Nutr J. 2013 Jun 7;12(1):76. doi: 10.1186/1475-2891-12-76.
- Derived from this study: PubMed 24265415Richard C, Couture P, Ooi EM, Tremblay AJ, Desroches S, Charest A, Lichtenstein AH, Lamarche B. Effect of Mediterranean diet with and without weight loss on apolipoprotein B100 metabolism in men with metabolic syndrome. Arterioscler Thromb Vasc Biol. 2014 Feb;34(2):433-8. doi: 10.1161/ATVBAHA.113.302185. Epub 2013 Nov 21.
- Derived from this study: PubMed 23505168Richard C, Couture P, Desroches S, Lamarche B. Effect of the Mediterranean diet with and without weight loss on markers of inflammation in men with metabolic syndrome. Obesity (Silver Spring). 2013 Jan;21(1):51-7. doi: 10.1002/oby.20239.
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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.
Benoît Lamarche, PhD study director
Institute of Nutraceutical and Functional Foods (INAF), 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 isocaloric diet and free living conditions in people with Cardiovascular Disease, 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 7 inclusion and 6 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 5 Mar 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 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?
plasma LDL, TG and HDL-C (time frame: Week 5, 10 and 35 (at the end of each weight-maintaining diet)). 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 NCT00988650, which also lists 4 linked publications.
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 5 Mar 2013.