Immune Benefits of Coffee

• Register: ClinicalTrials.gov
• Last refreshed on: 14 December 2015
• Main ID: NCT00860197
• Date of registration: 11/03/2009
• Prospective Registration: No
• Primary sponsor: University of Chile
• Public title: Immune Benefits of Coffee
• Scientific title: Effect of Coffee Consumption on Immune and Inflammatory Status in Elderly
• Date of first enrolment: March 2009
• Target sample size: 116
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00860197
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Chile

Contacts

• Name: Daniel Bunout, MD
• Affiliation: INTA University of Chile, Santiago, Metropolitana, Chile

Key inclusion & exclusion 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



Age minimum: 65 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Low-grade Inflammation

Immune Senescence

Intervention(s)

Dietary Supplement: Fully torrefied coffee

Dietary Supplement: Partially torrefied coffee

Primary Outcome(s)

NK-cell activity [Time Frame: will be measured before and after 30 days +/- treatment]

Tuberculin test [Time Frame: will be measured before and after 30 days +/- treatment]

Inflammatory status [Time Frame: will be measured before and after 30 days +/- treatment]

Secondary Outcome(s)

Gut microbiota profiling [Time Frame: will be measured before and after 30 days +/- treatment]

Secondary ID(s)

immunecoffee

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Nestlé