Effects of the Mediterranean Diet on Cardiovascular Risk Profile in Men and Women (ALIMED)

Laval University

Status

Completed

Conditions

Cardiovascular Diseases

Treatments

Other: Controlled nutritional intervention based on the Mediterranean diet

Study type

Interventional

Funder types

Other

Identifiers

NCT01293344

ALIMED-2007-180 A3 R-2

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

25 to 50 years old

Volunteers

No Healthy Volunteers

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