Immune Benefits of Coffee

This study has been completed.
Sponsor:
Collaborator:
Nestlé
Information provided by:
University of Chile
ClinicalTrials.gov Identifier:
NCT00860197
First received: March 11, 2009
Last updated: December 7, 2010
Last verified: March 2009
  Purpose

This study will assess whether coffee consumption:

  • increases immune responses
  • decreases inflammatory status

Condition Intervention
Immune Senescence
Low-grade Inflammation
Dietary Supplement: Control
Dietary Supplement: Fully torrefied coffee
Dietary Supplement: Partially torrefied coffee

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Coffee Consumption on Immune and Inflammatory Status in Elderly

Further study details as provided by University of Chile:

Primary Outcome Measures:
  • NK-cell activity [ Time Frame: will be measured before and after 30 days +/- treatment ] [ Designated as safety issue: No ]
  • Tuberculin test [ Time Frame: will be measured before and after 30 days +/- treatment ] [ Designated as safety issue: No ]
  • Inflammatory status [ Time Frame: will be measured before and after 30 days +/- treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gut microbiota profiling [ Time Frame: will be measured before and after 30 days +/- treatment ] [ Designated as safety issue: No ]

Enrollment: 116
Study Start Date: March 2009
Study Completion Date: February 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
No coffee
Dietary Supplement: Control
No coffee
Other Name: No coffee
Experimental: Group 1
Fully torrefied coffee
Dietary Supplement: Fully torrefied coffee
Fully torrefied coffee
Other Name: Fully torrefied coffee
Experimental: Group 2
Partially torrefied coffee
Dietary Supplement: Partially torrefied coffee
Partially torrefied coffee
Other Name: Partially torrefied coffee

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.

  Eligibility

Ages Eligible for Study:   65 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860197

Locations
Chile
INTA University of Chile
Santiago, Metropolitana, Chile, 7830489
Sponsors and Collaborators
University of Chile
Nestlé
Investigators
Principal Investigator: Daniel Bunout, MD INTA University of Chile, Santiago, Metropolitana, Chile
  More Information

Additional Information:
No publications provided

Responsible Party: University of Chile, Institute of Nutrition and Food Technology
ClinicalTrials.gov Identifier: NCT00860197     History of Changes
Other Study ID Numbers: immunecoffee
Study First Received: March 11, 2009
Last Updated: December 7, 2010
Health Authority: Chile: Ministry of Health

Keywords provided by University of Chile:
Coffee
Elderly
Immune response
Inflammatory status

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014