Effects of the Mediterranean Diet on Cardiovascular Risk Profile in Men and Women
- Conditions
- Cardiovascular Diseases
- Interventions
- Other: Controlled nutritional intervention based on the Mediterranean diet
- Registration Number
- NCT01293344
- Lead Sponsor
- Laval University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Men and Mediterranean diet Controlled nutritional intervention based on the Mediterranean diet Men who are assigned to a 4 weeks experimental diet formulated to be concordant with characteristics of the traditional Mediterranean diet. Women and Mediterranean diet Controlled nutritional intervention based on the Mediterranean diet Women who are assigned to a 4 weeks experimental diet formulated to be concordant with characteristics of the traditional Mediterranean diet.
- Primary Outcome Measures
Name Time Method Cardiometabolic outcomes 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.
- Secondary Outcome Measures
Name Time Method Nutritional variables 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). Dietary intakes
Eating behaviors At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks) Restraint, disinhibition, and susceptibility to hunger
Appetite ratings At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks) Desire to eat, hunger, fullness, and prospective food consumption
physical activity habits At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks) Weekly questionnaire about physical activities, a validated 3-day physical activity record (two weekdays and one weekend day)
Anthropometric measurements 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) Height, weight, body mass index, waist and hip circumferences,
Trial Locations
- Locations (1)
Institute of Nutraceuticals and Functional Foods (INAF), Laval University
🇨🇦Quebec, Canada