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

Laval University70 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Cardiovascular Diseases

Interventions

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.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Institute of Nutraceuticals and Functional Foods (INAF), Laval University

Québec, Quebec, Canada

Outcomes

Primary Outcomes

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.

Time frame: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks).

Secondary Outcomes

Nutritional variables

Dietary intakes

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

Restraint, disinhibition, and susceptibility to hunger

Time frame: 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

Time frame: 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)

Time frame: 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,

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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.