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Immune Benefits of Coffee

Primary Purpose

Immune Senescence, Low-grade Inflammation

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Fully torrefied coffee
Partially torrefied coffee
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Senescence focused on measuring Coffee, Elderly, Immune response, Inflammatory status

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • INTA University of Chile

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Group 1

Group 2

Arm Description

No coffee

Fully torrefied coffee

Partially torrefied coffee

Outcomes

Primary Outcome Measures

NK-cell activity
Tuberculin test
Inflammatory status

Secondary Outcome Measures

Gut microbiota profiling

Full Information

First Posted
March 11, 2009
Last Updated
November 30, 2015
Sponsor
University of Chile
Collaborators
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT00860197
Brief Title
Immune Benefits of Coffee
Official Title
Effect of Coffee Consumption on Immune and Inflammatory Status in Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
Collaborators
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Senescence, Low-grade Inflammation
Keywords
Coffee, Elderly, Immune response, Inflammatory status

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No coffee
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Fully torrefied coffee
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Partially torrefied coffee
Intervention Type
Dietary Supplement
Intervention Name(s)
Fully torrefied coffee
Intervention Description
Fully torrefied coffee
Intervention Type
Dietary Supplement
Intervention Name(s)
Partially torrefied coffee
Intervention Description
Partially torrefied coffee
Primary Outcome Measure Information:
Title
NK-cell activity
Time Frame
will be measured before and after 30 days +/- treatment
Title
Tuberculin test
Time Frame
will be measured before and after 30 days +/- treatment
Title
Inflammatory status
Time Frame
will be measured before and after 30 days +/- treatment
Secondary Outcome Measure Information:
Title
Gut microbiota profiling
Time Frame
will be measured before and after 30 days +/- treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Bunout, MD
Organizational Affiliation
INTA University of Chile, Santiago, Metropolitana, Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
INTA University of Chile
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
7830489
Country
Chile

12. IPD Sharing Statement

Links:
URL
http://www.inta.cl
Description
Web site of INTA University of Chile

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Immune Benefits of Coffee

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