Immune Benefits of Coffee

Low-grade Inflammation Clinical Trial

Official title:

Effect of Coffee Consumption on Immune and Inflammatory Status in Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00860197
• Other study ID #: immunecoffee
• Status: Completed
• Phase: N/A
• First received: March 11, 2009
• Last updated: November 30, 2015
• Start date: March 2009
• Est. completion date: February 2010

Study information

• Verified date: November 2015
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study will assess whether coffee consumption:

• increases immune responses

• decreases inflammatory status

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: February 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Immune Senescence
• Inflammation
• Low-grade Inflammation

Intervention

Dietary Supplement:
• Fully torrefied coffee
Fully torrefied coffee
• Partially torrefied coffee
Partially torrefied coffee

Locations

Country	Name	City	State
Chile	INTA University of Chile	Santiago	Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
University of Chile	Nestlé

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NK-cell activity		will be measured before and after 30 days +/- treatment	No
Primary	Tuberculin test		will be measured before and after 30 days +/- treatment	No
Primary	Inflammatory status		will be measured before and after 30 days +/- treatment	No
Secondary	Gut microbiota profiling		will be measured before and after 30 days +/- treatment	No

External Links

•   Web site of INTA University of Chile