- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Metropolitana
-
Santiago, Metropolitana, Chile, 7830489
- INTA University of Chile
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: Control
No coffee
|
|
|
Sperimentale: Group 1
Fully torrefied coffee
|
Fully torrefied coffee
|
|
Sperimentale: Group 2
Partially torrefied coffee
|
Partially torrefied coffee
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
NK-cell activity
Lasso di tempo: will be measured before and after 30 days +/- treatment
|
will be measured before and after 30 days +/- treatment
|
|
Tuberculin test
Lasso di tempo: will be measured before and after 30 days +/- treatment
|
will be measured before and after 30 days +/- treatment
|
|
Inflammatory status
Lasso di tempo: will be measured before and after 30 days +/- treatment
|
will be measured before and after 30 days +/- treatment
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Gut microbiota profiling
Lasso di tempo: will be measured before and after 30 days +/- treatment
|
will be measured before and after 30 days +/- treatment
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Daniel Bunout, MD, INTA University of Chile, Santiago, Metropolitana, Chile
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- immunecoffee
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .