Immune Benefits of Coffee

Study Overview
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Brief Summary
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This study will assess whether coffee consumption: increases immune responses decreases inflammatory status

Detailed Description
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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.

Official Title
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Effect of Coffee Consumption on Immune and Inflammatory Status in Elderly

Conditions
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Immune Senescence, Low-grade Inflammation

Intervention / Treatment
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* Dietary Supplement: Fully torrefied coffee
* Dietary Supplement: Partially torrefied coffee


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No coffee | |
| Experimental: Group 1<br>Fully torrefied coffee | Dietary Supplement: Fully torrefied coffee<br>* Fully torrefied coffee<br>|
| Experimental: Group 2<br>Partially torrefied coffee | Dietary Supplement: Partially torrefied coffee<br>* Partially torrefied coffee<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NK-cell activity |  | will be measured before and after 30 days +/- treatment | 
| Tuberculin test |  | will be measured before and after 30 days +/- treatment | 
| Inflammatory status |  | will be measured before and after 30 days +/- treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiota profiling |  | will be measured before and after 30 days +/- treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coffee, Elderly, Immune response, Inflammatory status