Effects of the Mediterranean Diet on Cardiovascular Risk Profile in Men and Women
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

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.
    

Intervention name(s): Controlled nutritional intervention based on the Mediterranean diet; Controlled nutritional intervention based on the Mediterranean diet
Intervention type(s): Other; Other
Intervention description(s): 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.; Women are assigned to the same intervention than men in order to compare men and women metabolic response to the MedDiet.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cardiovascular diseases; Controlled nutritional intervention; Sex differences; Women; Men; Cardiovascular risk; Lipid profile; Blood pressure; Insulin sensitivity; Inflammatory markers; Endothelial function; Oxidative stress