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

5 de outubro de 2011 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

70

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Canadá
      • Quebec, Canadá, G1V0A6
        • Institute of Nutraceuticals and Functional Foods (INAF), Laval University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

25 anos a 50 anos (Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Outro: 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.
Outro: 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: 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.
Outro: 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.
Outro: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Cardiometabolic outcomes
Prazo: 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).

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Nutritional variables
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Laval University

Colaboradores

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

Investigadores

  • Investigador principal: Simone Lemieux, Ph.D., Dt.P., Department of food sciences and nutrition / Institute of Nutraceutical and Functional Foods (INAF), Laval University

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de outubro de 2007

Conclusão Primária (Real)

1 de abril de 2010

Conclusão do estudo (Real)

1 de outubro de 2010

Datas de inscrição no estudo

Enviado pela primeira vez

9 de fevereiro de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de fevereiro de 2011

Primeira postagem (Estimativa)

10 de fevereiro de 2011

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

7 de outubro de 2011

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de outubro de 2011

Última verificação

1 de outubro de 2011

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • ALIMED-2007-180 A3 R-2

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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