Immune Benefits of Coffee
30. november 2015 opdateret af: Daniel Bunout, University of Chile
Effect of Coffee Consumption on Immune and Inflammatory Status in Elderly
This study will assess whether coffee consumption:
- increases immune responses
- decreases inflammatory status
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
116
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Metropolitana
-
Santiago, Metropolitana, Chile, 7830489
- INTA University of Chile
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
65 år til 90 år (Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Control
No coffee
|
|
|
Eksperimentel: Group 1
Fully torrefied coffee
|
Fully torrefied coffee
|
|
Eksperimentel: Group 2
Partially torrefied coffee
|
Partially torrefied coffee
|
Hvad måler undersøgelsen?
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Daniel Bunout, MD, INTA University of Chile, Santiago, Metropolitana, Chile
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2009
Primær færdiggørelse (Faktiske)
1. maj 2009
Studieafslutning (Faktiske)
1. februar 2010
Datoer for studieregistrering
Først indsendt
11. marts 2009
Først indsendt, der opfyldte QC-kriterier
11. marts 2009
Først opslået (Skøn)
12. marts 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
2. december 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. november 2015
Sidst verificeret
1. november 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- immunecoffee
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .