Immune Benefits of Coffee

NCT ID: NCT00860197

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-02-28

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.

Conditions

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Immune Senescence Low-grade Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

No coffee

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 1

Fully torrefied coffee

Group Type EXPERIMENTAL

Fully torrefied coffee

Intervention Type DIETARY_SUPPLEMENT

Fully torrefied coffee

Group 2

Partially torrefied coffee

Group Type EXPERIMENTAL

Partially torrefied coffee

Intervention Type DIETARY_SUPPLEMENT

Partially torrefied coffee

Interventions

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Fully torrefied coffee

Fully torrefied coffee

Intervention Type DIETARY_SUPPLEMENT

Partially torrefied coffee

Partially torrefied coffee

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role collaborator

University of Chile

OTHER

Sponsor Role lead

Responsible Party

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Daniel Bunout

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Bunout, MD

Role: PRINCIPAL_INVESTIGATOR

INTA University of Chile, Santiago, Metropolitana, Chile

Locations

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INTA University of Chile

Santiago, Santiago Metropolitan, Chile

Site Status

Countries

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Chile

Related Links

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http://www.inta.cl

Web site of INTA University of Chile

Other Identifiers

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immunecoffee

Identifier Type: -

Identifier Source: org_study_id