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OpenTrials
Completed

NCT Number: NCT00860197

Immune Benefits of Coffee

This study will assess whether coffee consumption:

* increases immune responses * decreases inflammatory status

Completed

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Key information

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INTA University of Chile

Santiago, Santiago Metropolitan, 7830489, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fully torrefied coffee

Dietary Supplement

Fully torrefied coffee

Partially torrefied coffee

Dietary Supplement

Partially torrefied coffee

Primary outcomes

  1. NK-cell activity

    Time frame: will be measured before and after 30 days +/- treatment

  2. Tuberculin test

    Time frame: will be measured before and after 30 days +/- treatment

  3. Inflammatory status

    Time frame: will be measured before and after 30 days +/- treatment

Secondary outcomes

  1. Gut microbiota profiling

    Time frame: will be measured before and after 30 days +/- treatment

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Collaborators

  • Société des Produits Nestlé (SPN)

Registry information

Official study title

Effect of Coffee Consumption on Immune and Inflammatory Status in Elderly

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Mar 12, 2009
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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