- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00860197
Immune Benefits of Coffee
Effect of Coffee Consumption on Immune and Inflammatory Status in Elderly
This study will assess whether coffee consumption:
- increases immune responses
- decreases inflammatory status
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Epidemiological studies suggest that coffee consumption is associated with protective effects against several types of chronic diseases. Recent data have shown that certain coffee components may possess anti-inflammatory and immune-enhancing properties. Low-grade inflammation and poor capacity of immune response is highly prevalent in elderly subjects.
The purpose of this study is to evaluate whether coffee consumption improves immune and inflammatory status in healthy elderly subjects. To sort out the role of antioxidants, we will test 2 different soluble coffee, i.e. fully torrefied coffee and partially torrefied coffee.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Metropolitana
-
Santiago, Metropolitana, Chile, 7830489
- INTA University of Chile
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Healthy, self-sufficient, free-living Chilean elderly
- Having the ability to comprehend the procedures of the study
- Having obtained his/her informed consent after verbal and written information
Exclusion Criteria:
- Subjects drinking more than 2 cups of coffee per day
- Subjects with rapidly deteriorating health status at enrolment in the study
- Subjects with terminal or acute disease, or unstable health status
- Subjects with chronic disease: chronic respiratory illness; chronic diseases of the pulmonary or cardiovascular systems (including asthma); chronic metabolic disease (diabetes); chronic renal disease, organ failure
- Subjects with serious neurological disorder, including dementia (MMSE < 20) or Alzheimer's disease
- Subjects who have experienced rapid weight loss, chronic diarrhea (loose stools, 3 times daily), or Crohn's (IBD)
- Subjects with gastrointestinal problems
- Subjects with a hospitalization planned during this study
- Subjects who have received any antibiotic treatment during the last 3 months prior to the beginning of this study
- Subjects who had a colonoscopy performed during the last 3 months prior to the beginning of this study
- Subjects with immune deficiency diseases (e.g. HIV infection)
- Subjects with a history of allergy - especially to egg protein, egg, shellfish or the antibiotics polymyxin or neomycin
- Subjects receiving medication that may influence the immune system (i.e. corticosteroids, immuno-suppressors and immuno-modulators, antimicrobials)
- Subjects who have received any vaccination during the last 15 days prior to baseline
- Subjects who are expected to be non-compliant
- Subjects currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
- Subjects participating in another research study involving any type of medication related to the study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Control
No coffee
|
|
|
Experimental: Group 1
Fully torrefied coffee
|
Fully torrefied coffee
|
|
Experimental: Group 2
Partially torrefied coffee
|
Partially torrefied coffee
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
NK-cell activity
Prazo: will be measured before and after 30 days +/- treatment
|
will be measured before and after 30 days +/- treatment
|
|
Tuberculin test
Prazo: will be measured before and after 30 days +/- treatment
|
will be measured before and after 30 days +/- treatment
|
|
Inflammatory status
Prazo: will be measured before and after 30 days +/- treatment
|
will be measured before and after 30 days +/- treatment
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Gut microbiota profiling
Prazo: will be measured before and after 30 days +/- treatment
|
will be measured before and after 30 days +/- treatment
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Daniel Bunout, MD, INTA University of Chile, Santiago, Metropolitana, Chile
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- immunecoffee
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 .