NCT00860197

Brief Summary

This study will assess whether coffee consumption:

  • increases immune responses
  • decreases inflammatory status

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

2 months

First QC Date

March 11, 2009

Last Update Submit

November 30, 2015

Conditions

Immune SenescenceLow-grade Inflammation

Keywords

CoffeeElderlyImmune responseInflammatory status

Outcome Measures

Primary Outcomes (3)

  • NK-cell activity

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

  • Tuberculin test

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

  • Inflammatory status

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

Secondary Outcomes (1)

  • Gut microbiota profiling

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

Study Arms (3)

Control

NO INTERVENTION

No coffee

Group 1

EXPERIMENTAL

Fully torrefied coffee

Dietary Supplement: Fully torrefied coffee

Group 2

EXPERIMENTAL

Partially torrefied coffee

Dietary Supplement: Partially torrefied coffee

Interventions

Fully torrefied coffeeDIETARY_SUPPLEMENT

Fully torrefied coffee

Group 1
Partially torrefied coffeeDIETARY_SUPPLEMENT

Partially torrefied coffee

Group 2

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INTA University of Chile

Santiago, Santiago Metropolitan, 7830489, Chile

Location

Related Links

Study Officials

  • Daniel Bunout, MD

    INTA University of Chile, Santiago, Metropolitana, Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 11, 2009

First Posted

March 12, 2009

Study Start

March 1, 2009

Primary Completion

May 1, 2009

Study Completion

February 1, 2010

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

CL(1)