Clinical trial NCT00860197: Immune Benefits of Coffee
Official title: Effect of Coffee Consumption on Immune and Inflammatory Status in Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune Senescence
Low-grade Inflammation
Keywords: Coffee
Elderly
Immune response
Inflammatory status
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: Société des Produits Nestlé (SPN)
First posted: 2009-03-12
Enrollment: 116
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess whether coffee consumption:

* increases immune responses
* decreases inflammatory status

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: NK-cell activity
timeFrame: will be measured before and after 30 days +/- treatment
measure: Tuberculin test
timeFrame: will be measured before and after 30 days +/- treatment
measure: Inflammatory status
timeFrame: will be measured before and after 30 days +/- treatment
Secondary outcomes:
measure: Gut microbiota profiling
timeFrame: will be measured before and after 30 days +/- treatment
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: INTA University of Chile
state: Metropolitana
Study officials:
affiliation: INTA University of Chile, Santiago, Metropolitana, Chile
name: Daniel Bunout, MD
role: PRINCIPAL_INVESTIGATOR
References: