Immune Benefits of Coffee

Not Applicable

Completed

• Conditions: Immune Senescence; Low-grade Inflammation
• Interventions: Dietary Supplement: Fully torrefied coffee; Dietary Supplement: Partially torrefied coffee

• Registration Number: NCT00860197
• Lead Sponsor: University of Chile

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-11
• Study First Submitted QC: 2009-03-11
• Study First Posted: 2009-03-12
• Primary Completion: 2009-05
• Study Completion: 2010-02
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Fully torrefied coffee	Fully torrefied coffee
Group 2	Partially torrefied coffee	Partially torrefied coffee

Primary Outcome Measures

Name	Time	Method
Tuberculin test	will be measured before and after 30 days +/- treatment
NK-cell activity	will be measured before and after 30 days +/- treatment
Inflammatory status	will be measured before and after 30 days +/- treatment

Secondary Outcome Measures

Name	Time	Method
Gut microbiota profiling	will be measured before and after 30 days +/- treatment

Trial Locations

Locations (1)

INTA University of Chile; 🇨🇱 Santiago, Metropolitana, Chile