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Pilot study to investigate the anti-inflammatory effects of caffeine in subjects with chronic obstructive pulmonary disease (COPD)

Pilot study to investigate the anti-inflammatory effects of caffeine in subjects with chronic obstructive pulmonary disease (COPD) - Anti-inflammatory effects of caffeine in COPD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON31548
Enrollment
12
Registered
2008-01-16
Start date
2009-01-07
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic inflammation chronic obstructive pulmonary disease (COPD)

Interventions

According to the cross-over design, the study comprises two intervention periods of one week which are separated by a wash-out period of three weeks. Subjects will participate in a one-week run-in p

Sponsors

Technologiestichting STW (NWO)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male subjects in an age of 40-70 years BMI > 20 kg/m2 and 3mg/l No acute and/or chronic inflammatory condition such as arthritis, arthrosis, chronic colitis, etc. during three months before entry of the study No respiratory tract infection or exacerbation of COPD for at least 8 weeks prior to the start of the study No change in treatment regime of the COPD subjects for at least 8 weeks prior to the start of the study Normal constant dietary eating habits and a usual coffee consumption of at least 3 cups per day Non-smokers and stopped smoking, respectively

Exclusion criteria

Exclusion criteria: Women age 70 years old BMI = 30 kg/m2 Diastolic blood pressure (DBP) 90 mmHg, systolic blood pressure (SBP) 150 mmHg 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 during the last 8 weeks prior to the start of the study Change in treatment regime of the COPD subjects during the last 8 weeks prior to the start of the study Irregular eating habits, usual coffee consumption of less than 3 cups per day and current smoker

Design outcomes

Primary

MeasureTime frame
The primary objective of the present study is to investigate the effects of a one-week daily supplementation of COPD patients with 2 x 250mg caffeine on biomarkers of systemic inflammation in blood such as C-reactive protein (CRP) and the cytokines TNF-a, IL-6, IL-8 and IL-10.

Secondary

MeasureTime frame
The secondary objectives of the study are 1) to investigate the effects of the one week caffeine supplementation on activation of poly-(ADP-ribose) polymerase I (PARP-I) and DNA-repair in peripheral blood lymphocytes by means of immune histochemical methods and the COMET assay. The COMET assay determines the level of DNA strand breaks, and is indicative for the amount of oxidative DNA lesions. 2) to investigate the effects of the one week caffeine supplementation on oxidative stress markers in urine such as the ratio of uric acid/allantoin (the oxidative metabolite of uric acid) and the creatinine levels 3) to determine the levels of caffeine and its metabolites in plasma and urine 4) to investigate the effects of the caffeine supplementation on organic volatiles (e.g. ethane, pentane and other (unknown) compounds that might be discriminatory for COPD patients) in exhaled air 5) to investigate the effects of the caffeine supplementation on the cytokine levels (TNF-a, IL-6, IL-8 and IL-10) in whole blood stimulated ex vivo with LPS. 6) to investigate the effects of the caffeine supplementation on the gene expression levels of cytokines, redox enzymes and other proteins involved in the inflammatory and oxidative stress response

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)