Immune SenescenceNCT00860197
Immune Benefits of Coffee
A study testing Fully torrefied coffee and Partially torrefied coffee in people with Immune Senescence and Low-grade Inflammation, run by University of Chile at 1 site in Chile.
Trial summary
This study will assess whether coffee consumption: increases immune responses decreases inflammatory status Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Senescence, Low-grade Inflammation
- What is being tested?
- Fully torrefied coffee and Partially torrefied coffee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChile
- Study dates
- Mar 2009to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Coffee Consumption on Immune and Inflammatory Status in Elderly
This study will assess whether coffee consumption:
- increases immune responses
- decreases inflammatory status
Read the 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.
- Conditions
- Immune Senescence, Low-grade Inflammation
- Being tested
- Fully torrefied coffee, Partially torrefied coffee
- Keywords
- Coffee, Elderly, Immune response, Inflammatory status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fully torrefied coffeeDietary supplement
Fully torrefied coffee
Partially torrefied coffeeDietary supplement
Partially torrefied coffee
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No coffee |
| Group 1 | Experimental | Fully torrefied coffee Receives: Dietary Supplement: Fully torrefied coffee |
| Group 2 | Experimental | Partially torrefied coffee Receives: Dietary Supplement: Partially torrefied coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
NK-cell activity
Measured: will be measured before and after 30 days +/- treatment
Tuberculin test
Measured: will be measured before and after 30 days +/- treatment
Inflammatory status
Measured: will be measured before and after 30 days +/- treatment
Secondary outcomes (1)
Gut microbiota profiling
Measured: will be measured before and after 30 days +/- treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune SenescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Responsible party
- Principal investigator, Daniel Bunout, University of Chile
- Investigators
- Daniel Bunout, MD, Principal investigator, INTA University of Chile, Santiago, Metropolitana, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860197
- Sponsor's protocol ID
- immunecoffee
- Status last verified
- Nov 2015
- First submitted
- 11 Mar 2009
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Coffee Consumption on Immune and Inflammatory Status in Elderly
- ClinicalTrials.gov ID
- NCT00860197
- Acronym / sponsor ID
- immunecoffee
- Conditions
- Immune Senescence, Low-grade Inflammation
- Keywords
- Coffee, Elderly, Immune response, Inflammatory status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Study start
- Mar 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 12 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No coffee |
| Group 1 | Experimental | Dietary Supplement: Fully torrefied coffeeFully torrefied coffee |
| Group 2 | Experimental | Dietary Supplement: Partially torrefied coffeePartially torrefied coffee |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fully torrefied coffeeFully torrefied coffee | Dietary supplement | Group 1 |
| Partially torrefied coffeePartially torrefied coffee | Dietary supplement | Group 2 |
Primary outcome
NK-cell activity
Time frame: will be measured before and after 30 days +/- treatment
Tuberculin test
Time frame: will be measured before and after 30 days +/- treatment
Inflammatory status
Time frame: will be measured before and after 30 days +/- treatment
1 secondary outcome
Gut microbiota profiling
Time frame: will be measured before and after 30 days +/- treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Web site of INTA University of ChileLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Bunout, MD principal investigator
INTA University of Chile, Santiago, Metropolitana, Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fully torrefied coffee and Partially torrefied coffee in people with Immune Senescence and Low-grade Inflammation, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NK-cell activity (time frame: will be measured before and after 30 days +/- treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.