Chronic Obstructive Pulmonary DiseaseNCT00826566
Anti-inflammatory Effects of Caffeine in Chronic Obstructive Pulmonary Disease (COPD) Subjects
A study testing Caffeine in people with Chronic Obstructive Pulmonary Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Nowadays it has become evident that a chronic systemic inflammation is present in patients suffering from chronic obstructive pulmonary disease (COPD). The role of the nuclear enzyme poly(adenosine diphosphate-ribose)polymerase (PARP) as a key mediator within these systemic inflammatory processes as well as in COPD… Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2009to Sep 2009
- 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 40 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD GOLD stage II (50% ≤ FEV1< 80%)
- CRP plasma levels ≥ 3 mg/l
- BMI > 20 kg/m2 and < 30 kg/m2
- Diastolic blood pressure (DBP)=60-90 mmHg, Systolic blood pressure (SBP)=100 150 mmHg
Who cannot join
- Physical and/or mental disease or major surgery in the present or the past that might limit participation in or completion of the study
- Reported current or previous metabolic (e.g. diabetes), cardiovascular and/or renal diseases
- Known presence of a carcinoma
- Acute and/or chronic inflammatory condition such as arthritis, arthrosis, chronic colitis, etc. during three months before entry of the study
- Respiratory tract infection or exacerbation of COPD for at least 8 weeks prior to the start of the study
- Change in treatment regime of the COPD subjects for at least 8 weeks prior to the start of the study
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- Use of laxatives, anti-diarrhoeal drugs and any other medication that can influence the uptake of the investigational products and/or influence their metabolism during the trial
- During the month prior to the start of the study and during the study the use of antibiotics and/or local and systemic steroidal (glucocorticoids) and non-steroidal anti-inflammatory drugs (NSAID)
- Abnormal constant dietary eating habits and a coffee consumption of less than 3 cups per day (i.e. a usual daily intake of <400 mg caffeine).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre (UMC+)
Maastricht, 6200 MD
About this study
Official title: Pilot Study to Investigate the Anti-inflammatory Effects of Caffeine in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Nowadays it has become evident that a chronic systemic inflammation is present in patients suffering from chronic obstructive pulmonary disease (COPD).
The role of the nuclear enzyme poly(adenosine diphosphate-ribose)polymerase (PARP) as a key mediator within these systemic inflammatory processes as well as in COPD associated exercise intolerance and muscle weakness could recently been identified. The attenuating effect of dietary ingredients with PARP inhibiting activity on systemic inflammation was supported by data from in vitro and in vivo studies, from other groups as well as from our own lab. We identified several caffeine metabolites as potent inhibitors of the most abundant PARP-isoform PARP-1 in-vitro, in animal models as well as in ex-vivo experiments with whole blood from COPD patients.
However, clinical data with respect to their anti-inflammatory effects in COPD patients are currently not available for none of these substances. Therefore, the current clinical pilot study is intended to establish for the first time clinical data (proof of principle) on the anti-inflammatory potential of caffeine metabolites.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Caffeine, placebo
- Keywords
- COPD, caffeine, chronic systemic inflammation, oxidative stress, supplementation, stable COPD GOLD stage II with CRP levels ≥ 3 mg/l
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDietary supplement
2 times 250 mg caffeine per day
placeboDietary supplement
2 times 250 mg per day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 500 mg caffeine capsules per day Receives: Dietary Supplement: Caffeine |
| 2 | Placebo comparator | 500 mg placebo capsules Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of C-reactive protein (CRP) and the cytokines TNF-a, IL-6, IL-8 and IL-10.
Measured: at the start and at the end of the intervention periods
Secondary outcomes (5)
Activation of poly-(ADP-ribose) polymerase (PARP)-1 activation and DNA repair in peripheral lymphocytes
Measured: at the start and the end of the intervention periods
Oxidative stress markers in plasma such as PGF2alpha
Measured: at the start and the end of the intervention periods
Plasma concentrations of caffeine and metabolites
Measured: at the start and the end of the interventions
Gene transcription levels of cytokines, redox enzymes and other proteins involved in inflammatory and oxidative stress response
Measured: at the start and the end of the interventions
Cytokine concentrations in whole blood after ex vivo stimulation with LPS
Measured: at the start and the end of the interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2009 (estimated)
- Study completionSep 2009 (estimated)
Why it stopped: Suitable subjects could not be recruited within the estimated time frame.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Technologiestichting STW (NWO)
- Responsible party
- Sponsor
- Investigators
- Geja J Hageman, PhD, Principal investigator, Dept. of Health Risk Analysis and Toxicology, UMC+, Maastricht, The NetherlandsAntje R Weseler, PhD, Principal investigator, Dept. of Pharmacology & Toxicology, UMC+, Maastricht, The NetherlandsAalt Bast, PhD, Prof., Study director, Dept. of Pharmacology & Toxicology, UMC+, Maastricht, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826566
- Sponsor's protocol ID
- STW6041
- Status last verified
- Sep 2009
- First submitted
- 21 Jan 2009
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Investigate the Anti-inflammatory Effects of Caffeine in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT00826566
- Acronym / sponsor ID
- STW6041
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, caffeine, chronic systemic inflammation, oxidative stress, supplementation, stable COPD GOLD stage II with CRP levels ≥ 3 mg/l
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Suitable subjects could not be recruited within the estimated time frame.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Technologiestichting STW (NWO)
- Study start
- Jan 2009
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 22 Jan 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.
Nowadays it has become evident that a chronic systemic inflammation is present in patients suffering from chronic obstructive pulmonary disease (COPD).
The role of the nuclear enzyme poly(adenosine diphosphate-ribose)polymerase (PARP) as a key mediator within these systemic inflammatory processes as well as in COPD associated exercise intolerance and muscle weakness could recently been identified. The attenuating effect of dietary ingredients with PARP inhibiting activity on systemic inflammation was supported by data from in vitro and in vivo studies, from other groups as well as from our own lab. We identified several caffeine metabolites as potent inhibitors of the most abundant PARP-isoform PARP-1 in-vitro, in animal models as well as in ex-vivo experiments with whole blood from COPD patients.
However, clinical data with respect to their anti-inflammatory effects in COPD patients are currently not available for none of these substances. Therefore, the current clinical pilot study is intended to establish for the first time clinical data (proof of principle) on the anti-inflammatory potential of caffeine metabolites.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Caffeine500 mg caffeine capsules per day |
| 2 | Placebo comparator | Dietary Supplement: placebo500 mg placebo capsules |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COPD GOLD stage II (50% ≤ FEV1< 80%)
- CRP plasma levels ≥ 3 mg/l
- BMI > 20 kg/m2 and < 30 kg/m2
- Diastolic blood pressure (DBP)=60-90 mmHg, Systolic blood pressure (SBP)=100 150 mmHg
Key exclusion criteria (9 listed)
- Physical and/or mental disease or major surgery in the present or the past that might limit participation in or completion of the study
- Reported current or previous metabolic (e.g. diabetes), cardiovascular and/or renal diseases
- Known presence of a carcinoma
- Acute and/or chronic inflammatory condition such as arthritis, arthrosis, chronic colitis, etc. during three months before entry of the study
- Respiratory tract infection or exacerbation of COPD for at least 8 weeks prior to the start of the study
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 |
|---|---|---|
| Caffeine2 times 250 mg caffeine per day | Dietary supplement | 1 |
| placebo2 times 250 mg per day | Dietary supplement | 2 |
Primary outcome
Plasma concentrations of C-reactive protein (CRP) and the cytokines TNF-a, IL-6, IL-8 and IL-10.
Time frame: at the start and at the end of the intervention periods
5 secondary outcomes
Activation of poly-(ADP-ribose) polymerase (PARP)-1 activation and DNA repair in peripheral lymphocytes
Time frame: at the start and the end of the intervention periods
Oxidative stress markers in plasma such as PGF2alpha
Time frame: at the start and the end of the intervention periods
Plasma concentrations of caffeine and metabolites
Time frame: at the start and the end of the interventions
Gene transcription levels of cytokines, redox enzymes and other proteins involved in inflammatory and oxidative stress response
Time frame: at the start and the end of the interventions
Cytokine concentrations in whole blood after ex vivo stimulation with LPS
Time frame: at the start and the end of the interventions
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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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.
Geja J Hageman, PhD principal investigator
Dept. of Health Risk Analysis and Toxicology, UMC+, Maastricht, The Netherlands
Antje R Weseler, PhD principal investigator
Dept. of Pharmacology & Toxicology, UMC+, Maastricht, The Netherlands
Aalt Bast, PhD, Prof. study director
Dept. of Pharmacology & Toxicology, UMC+, Maastricht, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine in people with Chronic Obstructive Pulmonary Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
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 4 inclusion and 9 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: withdrawn, as of the sponsor's last update on 23 Sep 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 Netherlands. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Plasma concentrations of C-reactive protein (CRP) and the cytokines TNF-a, IL-6, IL-8 and IL-10. (time frame: at the start and at the end of the intervention periods). 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 23 Sep 2015.