Clinical trial NCT01293344: Effects of the Mediterranean Diet on Cardiovascular Risk Profile in Men and Women
Official title: Gender Differences in Response to the Mediterranean Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Cardiovascular diseases
Controlled nutritional intervention
Sex differences
Women
Men
Cardiovascular risk
Lipid profile
Blood pressure
Insulin sensitivity
Inflammatory markers
Endothelial function
Oxidative stress
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Heart and Stroke Foundation of Canada
First posted: 2011-02-10
Enrollment: 70
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Cardiometabolic outcomes
timeFrame: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks).
Secondary outcomes:
measure: Nutritional variables
timeFrame: 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).
measure: Eating behaviors
timeFrame: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)
measure: Appetite ratings
timeFrame: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)
measure: physical activity habits
timeFrame: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)
measure: Anthropometric measurements
timeFrame: 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)
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Institute of Nutraceuticals and Functional Foods (INAF), Laval University
Study officials:
affiliation: Department of food sciences and nutrition / Institute of Nutraceutical and Functional Foods (INAF), Laval University
name: Simone Lemieux, Ph.D., Dt.P.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Bedard 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.
citation: Bedard 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.
citation: Bedard 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.