- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Metropolitana
-
Santiago, Metropolitana, Chile, 7830489
- INTA University of Chile
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: Control
No coffee
|
|
Eksperimentell: Group 1
Fully torrefied coffee
|
Fully torrefied coffee
|
Eksperimentell: Group 2
Partially torrefied coffee
|
Partially torrefied coffee
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
NK-cell activity
Tidsramme: will be measured before and after 30 days +/- treatment
|
will be measured before and after 30 days +/- treatment
|
Tuberculin test
Tidsramme: will be measured before and after 30 days +/- treatment
|
will be measured before and after 30 days +/- treatment
|
Inflammatory status
Tidsramme: will be measured before and after 30 days +/- treatment
|
will be measured before and after 30 days +/- treatment
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Gut microbiota profiling
Tidsramme: will be measured before and after 30 days +/- treatment
|
will be measured before and after 30 days +/- treatment
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Daniel Bunout, MD, INTA University of Chile, Santiago, Metropolitana, Chile
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- immunecoffee
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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