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Completed

NCT Number: NCT01293344

Effects of the Mediterranean Diet on Cardiovascular Risk Profile 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 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.

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Key information

Conditions

Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Genetic Diseases, Inborn Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Nutritional and Metabolic Diseases

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Nutraceuticals and Functional Foods (INAF), Laval University

Québec, Quebec, G1V0A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Controlled nutritional intervention based on the Mediterranean diet

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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,

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Heart and Stroke Foundation of Canada

Registry information

Official study title

Gender Differences in Response to the Mediterranean Diet

Acronym: ALIMED

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 10, 2011
Registry last updated
Oct 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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