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

Completed
Conditions
chronic inflammation
chronic obstructive pulmonary disease (COPD)
10038716
Registration Number
NL-OMON31548
Lead Sponsor
Technologiestichting STW (NWO)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
12
Inclusion Criteria

Male subjects in an age of 40-70 years
BMI > 20 kg/m2 and < 30 kg/m2
Diastolic blood pressure (DBP)=60-90 mmHg, Systolic blood pressure (SBP)=100-150 mmHg
CRP-levels > 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

Women
age < 40 years or > 70 years old
BMI <= 20 kg/m2 and >= 30 kg/m2
Diastolic blood pressure (DBP) < 60 or > 90 mmHg, systolic blood pressure (SBP) <100 or >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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary objective of the present study is to investigate the effects of a<br /><br>one-week daily supplementation of COPD patients with 2 x 250mg caffeine on<br /><br>biomarkers of systemic inflammation in blood such as C-reactive protein (CRP)<br /><br>and the cytokines TNF-a, IL-6, IL-8 and IL-10. </p><br>
Secondary Outcome Measures
NameTimeMethod
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