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

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ClinicalTrials.gov Identifier: NCT01293344
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : October 7, 2011
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Simone Lemieux, Laval University

February 9, 2011
February 10, 2011
October 7, 2011
October 2007
April 2010   (Final data collection date for primary outcome measure)
Cardiometabolic outcomes [ Time Frame: 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.
Same as current
Complete list of historical versions of study NCT01293344 on ClinicalTrials.gov Archive Site
  • 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). ]
    Dietary intakes
  • Eating behaviors [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ 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) ]
    Height, weight, body mass index, waist and hip circumferences,
Same as current
Not Provided
Not Provided
 
Effects of the Mediterranean Diet on Cardiovascular Risk Profile in Men and Women
Gender Differences in Response to the Mediterranean Diet
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.
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Cardiovascular Diseases
  • 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.
  • 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.
  • 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.
    Intervention: Other: Controlled nutritional intervention based on the Mediterranean diet
  • 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.
    Intervention: Other: Controlled nutritional intervention based on the Mediterranean diet

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
Same as current
October 2010
April 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
25 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01293344
ALIMED-2007-180 A3 R-2
No
Not Provided
Not Provided
Simone Lemieux, Laval University
Laval University
  • Canadian Institutes of Health Research (CIHR)
  • Heart and Stroke Foundation of Canada
Principal Investigator: Simone Lemieux, Ph.D., Dt.P. Department of food sciences and nutrition / Institute of Nutraceutical and Functional Foods (INAF), Laval University
Laval University
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP