Impact of Interventions With a Diet and Exercise on the Cardio-metabolic Status in Multi-risk Population (PANDEMONIO)
The diseases derived from Metabolic Syndrome caused 75% of the total deaths. It is more profitable to invest in prevention than in the treatment of most cardiovascular diseases. Several institutions consider prevention as one of the main priorities in public health.
Patients with Metabolic Syndrome, undergoing Mediterranean diet and exercise program, will have lower fat mass, greater lean mass and muscle strength; in addition to the lower expression of proinflammatory biomarkers, compared to those subjected to standard diet and exercise.
OBJECTIVE: To evaluate the changes in body composition and cardiovascular risk in the population with metabolic syndrome undergoing a Mediterranean diet program and / or controlled physical activity.
Design: Experimental, longitudinal design, controlled clinical trial, randomized. Population with Metabolic Syndrome in which the effect of Mediterranean diet and / or controlled physical activity will be compared on anthropometric parameters, body composition, cardiometabolic risk and plasma biomarkers.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Mexico City, México, 03100
- National Medical Center "20 de Noviembre", ISSSTE
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Patients with a diagnosis of metabolic syndrome.
- Patients diagnosed with overweight.
- Patients diagnosed with obesity.
- Patients with a diagnosis of systemic arterial hypertension.
- Patients diagnosed with type 2 diabetes mellitus.
- Patients with dyslipidemia.
Exclusion Criteria:
- Recent myocardial infarction
- Pregnancy
- Lactation
- In pharmacological treatment for weight loss.
- Cancer.
- Chronic kidney disease
- Liver failure
- Heart failure.
- Chronic obstructive pulmonary disease
- Depression
- Malabsorption syndrome
- Chronic diarrhea
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Mediterranean diet and exercise plan
Random assignment, through software, to 4 groups of treatment: consume the Mediterranean diet: according to the definition, with the distribution of macronutrients: Protein contribution 0.8-1.2
gram, Carbon Hydrates 45-50% Lipids 30% An exercise plan: The "classic" exercise program who they will carry out a 5-minute warm-up program with active mobilizations.
After that, they will perform intervals of 5 min with resistance to maintain the heart rate prescribed, with active breaks of 1 - 2 min, 4 repetitions.
At the end, there will be a return to calm The program of high-intensity anaerobic exercise will consist of a 5-minute warm-up , followed by 5 sets of isokinetic exercise with protocol "November 20", rest of 90 s between series.
The program will be done 3 times per week for 12 weeks.
|
Mediterranean diet: Diet: according to the definition, with the following distribution of macro nutrients: Protein contribution 0.8-1.2 Carbon Hydrates 45-50% Lipids 30% |
|
Experimental: Mediterranean diet
Random assignment, through software, to 4 groups of treatment: consume the Mediterranean diet: according to the definition, with the following distribution of macro nutrients: Protein contribution 0.8-1.2
gram Carbon Hydrates 45-50% Lipids 30%
|
Mediterranean diet: Diet: according to the definition, with the following distribution of macro nutrients: Protein contribution 0.8-1.2 Carbon Hydrates 45-50% Lipids 30% |
|
Comparador Ativo: Only exercise
An exercise plan: The "classic" exercise program who they will carry out a 5-minute warm-up program with active mobilizations.
After that, they will perform intervals of 5 min with resistance to maintain the heart rate prescribed, with active breaks of 1 - 2 min, 4 repetitions.
At the end, there will be a return to calm The program of high-intensity anaerobic exercise will consist of a 5-minute warm-up , followed by 5 sets of isokinetic exercise with protocol "November 20", rest of 90 s between series.
The program will be done 3 times per week for 12 weeks.
|
Mediterranean diet: Diet: according to the definition, with the following distribution of macro nutrients: Protein contribution 0.8-1.2 Carbon Hydrates 45-50% Lipids 30% |
|
Comparador Ativo: Low standard low fat diet
Random assignment, through software, to 4 groups of treatment: consume the low standard low fat diet: according to the definition, with the following distribution of macro nutrients:Protein contribution 0.8-1.2
Carbon Hydrates 45-50% Lipids 20%
|
Mediterranean diet: Diet: according to the definition, with the following distribution of macro nutrients: Protein contribution 0.8-1.2 Carbon Hydrates 45-50% Lipids 30% |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Measure the profiles of body composition in the different groups.
Prazo: 3 months
|
Measure the basal profiles of body composition (weight in kilograms and height in meters, body mass index in kg/m^2, bio impedance will be done by bioimpedance multifrequency, 8 points) in the different groups
|
3 months
|
|
Measure the profiles of pro inflammatory biomarkers.
Prazo: 3 months
|
Determine the basal pro-inflammatory biomarkers (interleukins 1 beta in picograms per liter , interleukin 2 in picograms per liter , interleukins 10 in picograms per liter ) in the 4 different groups.
|
3 months
|
|
Compare the profiles of body composition and proinflammatory biomarkers after the follow-up between the different groups in patients with metabolic syndrome.
Prazo: 3 months
|
To compare the profiles of body composition and proinflammatory biomarkers after a program of physical activity and feeding plan, in the different groups of patients with metabolic syndrome after the follow-up and classify by groups, responds or not responds for analysis
|
3 months
|
Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 083.2018
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .