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

NCT00826566 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-09-23

No results posted yet for this study

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 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

Interventions

DIETARY_SUPPLEMENT

Caffeine

2 times 250 mg caffeine per day

DIETARY_SUPPLEMENT

placebo

2 times 250 mg per day

Sponsors & Collaborators

  • Technologiestichting STW (NWO)

    collaborator UNKNOWN
  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Geja J Hageman, PhD · Dept. of Health Risk Analysis and Toxicology, UMC+, Maastricht, The Netherlands

  • Antje R Weseler, PhD · Dept. of Pharmacology & Toxicology, UMC+, Maastricht, The Netherlands

  • Aalt Bast, PhD, Prof. · Dept. of Pharmacology & Toxicology, UMC+, Maastricht, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-06-30
Completion
2009-09-30

Countries

  • Netherlands

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00826566 on ClinicalTrials.gov