Effects of the Mediterranean Diet on Cardiovascular Risk Profile in Men and Women (ALIMED)
5 octobre 2011 mis à jour par: Simone Lemieux, Laval University
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
70
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
-
Quebec, Canada, G1V0A6
- Institute of Nutraceuticals and Functional Foods (INAF), Laval University
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
25 ans à 50 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
Women are assigned to the same intervention than men in order to compare men and women metabolic response to the MedDiet.
|
|
Expérimental: 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.
|
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.
Women are assigned to the same intervention than men in order to compare men and women metabolic response to the MedDiet.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cardiometabolic outcomes
Délai: 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.
|
At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Nutritional variables
Délai: 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
|
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).
|
|
Eating behaviors
Délai: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)
|
Restraint, disinhibition, and susceptibility to hunger
|
At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)
|
|
Appetite ratings
Délai: 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
|
At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)
|
|
physical activity habits
Délai: 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)
|
At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)
|
|
Anthropometric measurements
Délai: 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,
|
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)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Simone Lemieux, Ph.D., Dt.P., Department of food sciences and nutrition / Institute of Nutraceutical and Functional Foods (INAF), Laval University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Bedard A, Lamarche B, Corneau L, Dodin S, Lemieux S. Sex differences in the impact of the Mediterranean diet on systemic inflammation. Nutr J. 2015 May 12;14:46. doi: 10.1186/s12937-015-0035-y.
- Bedard A, Corneau L, Lamarche B, Dodin S, Lemieux S. Sex-related differences in the effects of the mediterranean diet on glucose and insulin homeostasis. J Nutr Metab. 2014;2014:424130. doi: 10.1155/2014/424130. Epub 2014 Oct 9.
- Bedard A, Tchernof A, Lamarche B, Corneau L, Dodin S, Lemieux S. Effects of the traditional Mediterranean diet on adiponectin and leptin concentrations in men and premenopausal women: do sex differences exist? Eur J Clin Nutr. 2014 May;68(5):561-6. doi: 10.1038/ejcn.2014.27. Epub 2014 Mar 5.
- Bedard A, Dodin S, Corneau L, Lemieux S. Impact of the traditional Mediterranean diet on the Framingham risk score and the metabolic syndrome according to sex. Metab Syndr Relat Disord. 2014 Mar;12(2):95-101. doi: 10.1089/met.2012.0076. Epub 2014 Jan 17.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 octobre 2007
Achèvement primaire (Réel)
1 avril 2010
Achèvement de l'étude (Réel)
1 octobre 2010
Dates d'inscription aux études
Première soumission
9 février 2011
Première soumission répondant aux critères de contrôle qualité
9 février 2011
Première publication (Estimation)
10 février 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
7 octobre 2011
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 octobre 2011
Dernière vérification
1 octobre 2011
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ALIMED-2007-180 A3 R-2
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .