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

Cardiovascular Diseases Clinical Trial

— ALIMED  

Official title:

Gender Differences in Response to the Mediterranean Diet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293344
• Other study ID #: ALIMED-2007-180 A3 R-2
• Status: Completed
• Phase: N/A
• First received: February 9, 2011
• Last updated: October 5, 2011
• Start date: October 2007
• Est. completion date: October 2010

Study information

• Verified date: October 2011
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research (CIHR)
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 50 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Other:
• Controlled 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.
• Controlled nutritional intervention based on the Mediterranean diet
Women are assigned to the same intervention than men in order to compare men and women metabolic response to the MedDiet.

Locations

Country	Name	City	State
Canada	Institute of Nutraceuticals and Functional Foods (INAF), Laval University	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Laval University	Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks).	No
Secondary	Nutritional variables	Dietary intakes	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).	No
Secondary	Eating behaviors	Restraint, disinhibition, and susceptibility to hunger	At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)	No
Secondary	Appetite ratings	Desire to eat, hunger, fullness, and prospective food consumption	At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)	No
Secondary	physical activity habits	Weekly questionnaire about physical activities, a validated 3-day physical activity record (two weekdays and one weekend day)	At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)	No
Secondary	Anthropometric measurements	Height, weight, body mass index, waist and hip circumferences,	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)	No