Cardiovascular Diseases
Conditions
Keywords
Cardiovascular diseases, Controlled nutritional intervention, Sex differences, Women, Men, Cardiovascular risk, Lipid profile, Blood pressure, Insulin sensitivity, Inflammatory markers, Endothelial function, Oxidative stress
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.
Interventions
OTHERControlled nutritional intervention based on the Mediterranean diet
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.
Sponsors
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Laval University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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, |
Countries
Canada
Outcome results
None listed