Cardiovascular DiseasesALIMEDNCT01293344
Effects of the Mediterranean Diet on Cardiovascular Risk Profile in Men and Women
A study of Cardiovascular Diseases, run by Laval University at 1 site in Canada.
Trial summary
The purpose of this study is to document differences between men and women in changes in metabolic variables associated with cardiovascular risk in response to a 4 weeks isocaloric controlled nutritional intervention based on the Mediterranean diet in which all foods and drinks are provided to subjects. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Cardiovascular Diseases
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2007to Oct 2010
- 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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and premenopausal women from de Quebec City metropolitan area.
- Slightly elevated LDL-cholesterol concentrations (3.4-4.9 mM) or total cholesterol to HDL-C ratio ≥ 5.0
- At least one of the four following factors of the metabolic syndrome: 1) waist circumference > 94 cm in men and > 80 cm in women; 2) TG > 1.7 mmol/L; 3) fasting glycemia between 6.1 and 6.9 mmol/L and 4) blood pressure concentrations ≥ 130 / 85 mm Hg.
- Age: between 25 to 50 years
- Stable body weight (+/- 2.5 kg) for at least 3 months before the beginning of the study
- In women, a regular menstrual cycle for the last 3 months
Who cannot join
- Subjects with endocrine disorders, cardiovascular events, type 1 or 2 diabetes and those using medication that could affect dependent variables measured (namely lipid-lowering, hypoglycemic, insulin sensitizers and anti hypertensive medication)
- Smokers
- Subjects with history of alcoholism
- Subjects with food allergies or food aversion that could impede compliance to the Mediterranean diet
- Pregnant women and those using systemic hormonal contraceptives
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institute of Nutraceuticals and Functional Foods (INAF), Laval University
Québec, Quebec, G1V0A6
About this study
Official title: Gender Differences in Response to the Mediterranean Diet
The purpose of this study is to document differences between men and women in changes in metabolic variables associated with cardiovascular risk in response to a 4 weeks isocaloric controlled nutritional intervention based on the Mediterranean diet in which all foods and drinks are provided to subjects. The investigators hypothesize that the decrease in LDL-cholesterol will be more important in men than in women.
Read the detailed description
Nutritional interventions promoting the adoption of the traditional Mediterranean diet (MedDiet) are known to have significant and beneficial effects on cardiovascular disease (CVD) risk profile. On the other hand, recent evidence suggests that women respond differently to diet than men. No study has yet compared men and women metabolic response to the MedDiet in a controlled metabolic context in which all foods and drinks consumed are provided to the participant prepared by the research team. Therefore, we do not know whether being fed a MedDiet in controlled conditions would have similar health benefits in men and women. The purpose of this study is to document differences between men and women in changes in metabolic variables associated with cardiovascular risk in response to a 4 weeks isocaloric controlled nutritional intervention based on the MedDiet in which all foods and drinks are provided to subjects. We hypothesize that the decrease in LDL-cholesterol will be more important in men than in women. In this parallel controlled trial, both men and women are assigned to the same 4 weeks experimental diet formulated to be concordant with characteristics of the traditional MedDiet. Data will be collected before and after the controlled nutritional intervention based on the MedDiet.
- Conditions
- Cardiovascular Diseases
- Being tested
- Controlled nutritional intervention based on the Mediterranean diet
- Keywords
- Cardiovascular diseases, Controlled nutritional intervention, Sex differences, Women, Men, Cardiovascular risk, Lipid profile, Blood pressure, Insulin sensitivity, Inflammatory markers, Endothelial function, Oxidative stress
- Medical subject headings
- Cardiovascular Diseases, Multiple Endocrine Neoplasia Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled nutritional intervention based on the Mediterranean dietOther
Men are assigned to a 4 weeks isocaloric controlled nutritional intervention based on the Mediterranean diet (MedDiet) in which all foods and drinks are provided. The respective percentages of kcal derived from lipids, carbohydrates, protein and alcohol are respectively of 32%, 48%, 15% and 5%. Habitual energy intake of each participant is established by averaging energy requirements estimated by a validated food-frequency questionnaire (FFQ) and energy needs as determined by the Harris-Benedict formula. Body weight is measured on weekdays and total energy provided is revised if necessary for minimizing body weight fluctuations. This intervention period is preceded by a 4 weeks uncontrolled run-in period based on the Canada's Food Guide.
Controlled nutritional intervention based on the Mediterranean dietOther
Women are assigned to the same intervention than men in order to compare men and women metabolic response to the MedDiet.
| Study group | Role | What they receive |
|---|---|---|
| Men and Mediterranean diet | Experimental | Men who are assigned to a 4 weeks experimental diet formulated to be concordant with characteristics of the traditional Mediterranean diet. Receives: Other: Controlled nutritional intervention based on the Mediterranean diet |
| Women and Mediterranean diet | Experimental | Women who are assigned to a 4 weeks experimental diet formulated to be concordant with characteristics of the traditional Mediterranean diet. Receives: Other: Controlled nutritional intervention based on the Mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiometabolic outcomes
Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, apolipoprotein (apo) B, apo A-1 and apo A-2 plasma concentrations, systolic and diastolic blood pressure, glucose and insulin concentrations during a 180-min oral glucose tolerance test, insulin sensitivity, CRP and Interleukine-6 levels, oxidized-LDL, E-selectin, ICAM-1 and VCAM-1.
Measured: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks).
Secondary outcomes (5)
Nutritional variables
Dietary intakes
Measured: At baseline (at the beginning of the intervention), at the end of the intervention period (4 weeks) and at 6-months post-intervention (28 weeks).
Eating behaviors
Restraint, disinhibition, and susceptibility to hunger
Measured: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)
Appetite ratings
Desire to eat, hunger, fullness, and prospective food consumption
Measured: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)
physical activity habits
Weekly questionnaire about physical activities, a validated 3-day physical activity record (two weekdays and one weekend day)
Measured: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)
Anthropometric measurements
Height, weight, body mass index, waist and hip circumferences,
Measured: At baseline (at the beginning of the intervention), at the end of the intervention period (4 weeks) and at 6-months post-intervention (28 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startOct 2007
- Primary completionApr 2010
- Study completionOct 2010
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 DiseasesStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada
- Responsible party
- Principal investigator, Simone Lemieux, Laval University
- Investigators
- Simone Lemieux, Ph.D., Dt.P., Principal investigator, Department of food sciences and nutrition / Institute of Nutraceutical and Functional Foods (INAF), Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293344
- Sponsor's protocol ID
- ALIMED-2007-180 A3 R-2
- Acronym
- ALIMED
- Status last verified
- Oct 2011
- First submitted
- 9 Feb 2011
- Last updated
- 7 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Bedard A, Lamarche B, Corneau L, Dodin S, Lemieux S. Sex differences in the impact of the Mediterranean diet on systemic inflammation. Nutr J. 2015 May 12;14:46. doi: 10.1186/s12937-015-0035-y.
PubMed 25962728Bedard A, Corneau L, Lamarche B, Dodin S, Lemieux S. Sex-related differences in the effects of the mediterranean diet on glucose and insulin homeostasis. J Nutr Metab. 2014;2014:424130. doi: 10.1155/2014/424130. Epub 2014 Oct 9.
PubMed 25371817Bedard A, Tchernof A, Lamarche B, Corneau L, Dodin S, Lemieux S. Effects of the traditional Mediterranean diet on adiponectin and leptin concentrations in men and premenopausal women: do sex differences exist? Eur J Clin Nutr. 2014 May;68(5):561-6. doi: 10.1038/ejcn.2014.27. Epub 2014 Mar 5.
PubMed 24595221Bedard A, Dodin S, Corneau L, Lemieux S. Impact of the traditional Mediterranean diet on the Framingham risk score and the metabolic syndrome according to sex. Metab Syndr Relat Disord. 2014 Mar;12(2):95-101. doi: 10.1089/met.2012.0076. Epub 2014 Jan 17.
PubMed 24438432
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Differences in Response to the Mediterranean Diet
- ClinicalTrials.gov ID
- NCT01293344
- Acronym / sponsor ID
- ALIMED / ALIMED-2007-180 A3 R-2
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiovascular diseases, Controlled nutritional intervention, Sex differences, Women, Men, Cardiovascular risk, Lipid profile, Blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada
- Study start
- Oct 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 10 Feb 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.
The purpose of this study is to document differences between men and women in changes in metabolic variables associated with cardiovascular risk in response to a 4 weeks isocaloric controlled nutritional intervention based on the Mediterranean diet in which all foods and drinks are provided to subjects. The investigators hypothesize that the decrease in LDL-cholesterol will be more important in men than in women.
Detailed description
Nutritional interventions promoting the adoption of the traditional Mediterranean diet (MedDiet) are known to have significant and beneficial effects on cardiovascular disease (CVD) risk profile. On the other hand, recent evidence suggests that women respond differently to diet than men. No study has yet compared men and women metabolic response to the MedDiet in a controlled metabolic context in which all foods and drinks consumed are provided to the participant prepared by the research team. Therefore, we do not know whether being fed a MedDiet in controlled conditions would have similar health benefits in men and women. The purpose of this study is to document differences between men and women in changes in metabolic variables associated with cardiovascular risk in response to a 4 weeks isocaloric controlled nutritional intervention based on the MedDiet in which all foods and drinks are provided to subjects. We hypothesize that the decrease in LDL-cholesterol will be more important in men than in women. In this parallel controlled trial, both men and women are assigned to the same 4 weeks experimental diet formulated to be concordant with characteristics of the traditional MedDiet. Data will be collected before and after the controlled nutritional intervention based on the MedDiet.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Men and Mediterranean diet | Experimental | Other: Controlled nutritional intervention based on the Mediterranean dietMen who are assigned to a 4 weeks experimental diet formulated to be concordant with characteristics of the traditional Mediterranean diet. |
| Women and Mediterranean diet | Experimental | Other: Controlled nutritional intervention based on the Mediterranean dietWomen who are assigned to a 4 weeks experimental diet formulated to be concordant with characteristics of the traditional Mediterranean diet. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Men and premenopausal women from de Quebec City metropolitan area.
- Slightly elevated LDL-cholesterol concentrations (3.4-4.9 mM) or total cholesterol to HDL-C ratio ≥ 5.0
- At least one of the four following factors of the metabolic syndrome: 1) waist circumference > 94 cm in men and > 80 cm in women; 2) TG > 1.7 mmol/L; 3) fasting glycemia between 6.1 and 6.9 mmol/L and 4) blood pressure concentrations ≥ 130 / 85 mm Hg.
- Age: between 25 to 50 years
- Stable body weight (+/- 2.5 kg) for at least 3 months before the beginning of the study
Key exclusion criteria (5 listed)
- Subjects with endocrine disorders, cardiovascular events, type 1 or 2 diabetes and those using medication that could affect dependent variables measured (namely lipid-lowering, hypoglycemic, insulin sensitizers and anti hypertensive medication)
- Smokers
- Subjects with history of alcoholism
- Subjects with food allergies or food aversion that could impede compliance to the Mediterranean diet
- Pregnant women and those using systemic hormonal contraceptives
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 |
|---|---|---|
| Controlled nutritional intervention based on the Mediterranean dietMen are assigned to a 4 weeks isocaloric controlled nutritional intervention based on the Mediterranean diet (MedDiet) in which all foods and drinks are provided. The respective percentages of kcal derived from lipids, carbohydrates, protein and alcohol are respectively of 32%, 48%, 15% and 5%. Habitual energy intake of each participant is established by averaging energy requirements estimated by a validated food-frequency questionnaire (FFQ) and energy needs as determined by the Harris-Benedict formula. Body weight is measured on weekdays and total energy provided is revised if necessary for minimizing body weight fluctuations. This intervention period is preceded by a 4 weeks uncontrolled run-in period based on the Canada's Food Guide. | Other | Men and Mediterranean diet |
| Controlled nutritional intervention based on the Mediterranean dietWomen are assigned to the same intervention than men in order to compare men and women metabolic response to the MedDiet. | Other | Women and Mediterranean diet |
Primary outcome
Cardiometabolic outcomes
Time frame: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks).
Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, apolipoprotein (apo) B, apo A-1 and apo A-2 plasma concentrations, systolic and diastolic blood pressure, glucose and insulin concentrations during a 180-min oral glucose tolerance test, insulin sensitivity, CRP and Interleukine-6 levels, oxidized-LDL, E-selectin, ICAM-1 and VCAM-1.
5 secondary outcomes
Nutritional variables
Time frame: At baseline (at the beginning of the intervention), at the end of the intervention period (4 weeks) and at 6-months post-intervention (28 weeks).
Eating behaviors
Time frame: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)
Appetite ratings
Time frame: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)
physical activity habits
Time frame: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)
Anthropometric measurements
Time frame: At baseline (at the beginning of the intervention), at the end of the intervention period (4 weeks) and at 6-months post-intervention (28 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 Oct 2011.
- Derived from this study: PubMed 25962728Bedard A, Lamarche B, Corneau L, Dodin S, Lemieux S. Sex differences in the impact of the Mediterranean diet on systemic inflammation. Nutr J. 2015 May 12;14:46. doi: 10.1186/s12937-015-0035-y.
- Derived from this study: PubMed 25371817Bedard A, Corneau L, Lamarche B, Dodin S, Lemieux S. Sex-related differences in the effects of the mediterranean diet on glucose and insulin homeostasis. J Nutr Metab. 2014;2014:424130. doi: 10.1155/2014/424130. Epub 2014 Oct 9.
- Derived from this study: PubMed 24595221Bedard A, Tchernof A, Lamarche B, Corneau L, Dodin S, Lemieux S. Effects of the traditional Mediterranean diet on adiponectin and leptin concentrations in men and premenopausal women: do sex differences exist? Eur J Clin Nutr. 2014 May;68(5):561-6. doi: 10.1038/ejcn.2014.27. Epub 2014 Mar 5.
- Derived from this study: PubMed 24438432Bedard A, Dodin S, Corneau L, Lemieux S. Impact of the traditional Mediterranean diet on the Framingham risk score and the metabolic syndrome according to sex. Metab Syndr Relat Disord. 2014 Mar;12(2):95-101. doi: 10.1089/met.2012.0076. Epub 2014 Jan 17.
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
Simone Lemieux, Ph.D., Dt.P. principal investigator
Department of food sciences and nutrition / 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 of Cardiovascular Diseases, 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 5 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 Oct 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 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?
Cardiometabolic outcomes (time frame: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks).). 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 NCT01293344, 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 7 Oct 2011.