Status:
COMPLETED
Low Grade Inflammation, Gut Microbiota and Barrier Function in Elderly Humans
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Aged
Healthy
Eligibility:
MALE
65-85 years
Phase:
EARLY_PHASE1
Brief Summary
Cardiovascular diseases (CVD) are the main cause of death in the European Union. A large part of the aging process, including immunosenescence, is explained by an imbalance between inflammatory and an...
Detailed Description
Cardiovascular diseases (CVD) are the main cause of death in the European Union. A large part of the aging process, including immunosenescence, is explained by an imbalance between inflammatory and an...
Eligibility Criteria
Inclusion
- Men \>65 years of age.
- Body mass index: 22-34,9 kg/m²
- non-smokers
- Intervention trial:
- hsCRP \> 1 mg/L (Screening blood test)
- normal blood count (Screening blood test)
- normal ALAT, ASAT and serum creatinine levels (Screening blood test)
Exclusion
- any major non-organic disease, including malign diseases (haematological, inflammatory, metabolic,)
- any major organ disease, including neoplastic diseases.
- intake of antibiotics within the last 6 weeks
- chronic therapy with analgetics (incl. acetylsalicylic acid)
- chronic therapy with proton pump inhibitors
- regular intake of probiotic bacteria products within the last 3 weeks
- chronic anti-inflammatory therapy with NSARs or previous therapy within the last 20 days
- subjects with expected non-compliance to protocol guidelines
- subjects that participate in other trials
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01218165
Start Date
May 1 2010
End Date
May 1 2011
Last Update
October 28 2011
Active Locations (1)
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1
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany, 10117