- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Metropolitana
-
Santiago, Metropolitana, Chile, 7830489
- INTA University of Chile
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
No coffee
|
|
Experimental: Group 1
Fully torrefied coffee
|
Fully torrefied coffee
|
Experimental: Group 2
Partially torrefied coffee
|
Partially torrefied coffee
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
NK-cell activity
Time Frame: will be measured before and after 30 days +/- treatment
|
will be measured before and after 30 days +/- treatment
|
Tuberculin test
Time Frame: will be measured before and after 30 days +/- treatment
|
will be measured before and after 30 days +/- treatment
|
Inflammatory status
Time Frame: will be measured before and after 30 days +/- treatment
|
will be measured before and after 30 days +/- treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Gut microbiota profiling
Time Frame: will be measured before and after 30 days +/- treatment
|
will be measured before and after 30 days +/- treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Daniel Bunout, MD, INTA University of Chile, Santiago, Metropolitana, Chile
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- immunecoffee
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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