Anti-inflammatory Effects of Caffeine in Chronic Obstructive Pulmonary Disease (COPD) Subjects

This study has been withdrawn prior to enrollment.
(Suitable subjects could not be recruited within the estimated time frame and via the objected ways of recruitment.)
Sponsor:
Collaborator:
Technologiestichting STW (NWO)
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00826566
First received: January 21, 2009
Last updated: September 17, 2009
Last verified: September 2009

January 21, 2009
September 17, 2009
January 2009
June 2009   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00826566 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Oxidative stress markers in plasma such as PGF2alpha [ Time Frame: at the start and the end of the intervention periods ] [ Designated as safety issue: No ]
  • Plasma concentrations of caffeine and metabolites [ Time Frame: at the start and the end of the interventions ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Cytokine concentrations in whole blood after ex vivo stimulation with LPS [ Time Frame: at the start and the end of the interventions ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Anti-inflammatory Effects of Caffeine in Chronic Obstructive Pulmonary Disease (COPD) Subjects
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Chronic Obstructive Pulmonary Disease
  • Dietary Supplement: Caffeine
    2 times 250 mg caffeine per day
  • Dietary Supplement: placebo
    2 times 250 mg per day
  • Active Comparator: 1
    caffeine
    Intervention: Dietary Supplement: Caffeine
  • Placebo Comparator: 2
    placebo
    Intervention: Dietary Supplement: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
12
September 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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).
Male
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00826566
STW6041
No
Ir. C.H. Kemper, Technologiestichting STW (NWO), PO Box 3021, 3502 GA Utrecht, The Netherlands
Maastricht University Medical Center
Technologiestichting STW (NWO)
Principal Investigator: Geja J Hageman, PhD Dept. of Health Risk Analysis and Toxicology, UMC+, Maastricht, The Netherlands
Principal Investigator: Antje R Weseler, PhD Dept. of Pharmacology & Toxicology, UMC+, Maastricht, The Netherlands
Study Director: Aalt Bast, PhD, Prof. Dept. of Pharmacology & Toxicology, UMC+, Maastricht, The Netherlands
Maastricht University Medical Center
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP