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

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Simone Lemieux, Laval University
ClinicalTrials.gov Identifier:
NCT01293344
First received: February 9, 2011
Last updated: October 5, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Other: Controlled nutritional intervention based on the Mediterranean diet

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Gender Differences in Response to the Mediterranean Diet

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • Cardiometabolic outcomes [ Time Frame: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks). ] [ Designated as safety issue: No ]
    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:
  • Nutritional variables [ 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). ] [ Designated as safety issue: No ]
    Dietary intakes

  • Eating behaviors [ Time Frame: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks) ] [ Designated as safety issue: No ]
    Restraint, disinhibition, and susceptibility to hunger

  • Appetite ratings [ Time Frame: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks) ] [ Designated as safety issue: No ]
    Desire to eat, hunger, fullness, and prospective food consumption

  • physical activity habits [ Time Frame: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks) ] [ Designated as safety issue: No ]
    Weekly questionnaire about physical activities, a validated 3-day physical activity record (two weekdays and one weekend day)

  • Anthropometric measurements [ 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) ] [ Designated as safety issue: No ]
    Height, weight, body mass index, waist and hip circumferences,


Enrollment: 70
Study Start Date: October 2007
Study Completion Date: October 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Men and Mediterranean diet
Men who are assigned to a 4 weeks experimental diet formulated to be concordant with characteristics of the traditional Mediterranean diet.
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.
Experimental: Women and Mediterranean diet
Women who are assigned to a 4 weeks experimental diet formulated to be concordant with characteristics of the traditional Mediterranean diet.
Other: 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.

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.

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01293344

Locations
Canada
Institute of Nutraceuticals and Functional Foods (INAF), Laval University
Quebec, Canada, G1V0A6
Sponsors and Collaborators
Laval University
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Investigators
Principal Investigator: Simone Lemieux, Ph.D., Dt.P. Department of food sciences and nutrition / Institute of Nutraceutical and Functional Foods (INAF), Laval University
  More Information

No publications provided by Laval University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Simone Lemieux, Professor, Laval University
ClinicalTrials.gov Identifier: NCT01293344     History of Changes
Other Study ID Numbers: ALIMED-2007-180 A3 R-2
Study First Received: February 9, 2011
Last Updated: October 5, 2011
Health Authority: Canada: Canadian Institutes of Health Research (CIHR)

Keywords provided by Laval University:
Cardiovascular diseases
Controlled nutritional intervention
Sex differences
Women
Men
Cardiovascular risk
Lipid profile
Blood pressure
Insulin sensitivity
Inflammatory markers
Endothelial function
Oxidative stress

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 19, 2014