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

Maastricht University Medical Centre (MUMC)

Status

Withdrawn

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Dietary Supplement: Caffeine

Dietary Supplement: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00826566

STW6041

Details and patient eligibility

About

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.

Sex

Male

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

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).