The Inflammaging Network: Bridging Low Grade Inflammation With Gut Microbiota and Intestinal Barrier Function in Elderly Humans
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Pre/post-intervention change in hsCRP
Study Overview
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 anti-inflammatory networks, wich results in the low grade chronic pro-inflammatory status termed inflammaging. It can contribute to a number of age-related chronic diseases (e.g. atherosclerosis, type 2 diabetes, Alzheimer disease, osteoporosis). Prevention or delay in onset of chronic diseases can potentially benefit a large segment of the elderly population. Now it is hypothesised that a probiotic drink can reduce low-grade inflammation through improvement of the gut barrier function and gut microbiota composition in elderly people with low-grade inflammation.
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 anti-inflammatory networks, wich results in the low grade chronic pro-inflammatory status termed inflammaging. It can contribute to a number of age-related chronic diseases (e.g. atherosclerosis, type 2 diabetes, Alzheimer disease, osteoporosis). Prevention or delay in onset of chronic diseases can potentially benefit a large segment of the elderly population. Now it is hypothesised that a probiotic drink can reduce low-grade inflammation through improvement of the gut barrier function and gut microbiota composition in elderly people with low-grade inflammation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to 85 Years (Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Control Group
without intervention
Intervention: Control Group (Other)
Intervention Group
This group receives a probiotic drink daily for 6 week.
Intervention: Probiotic drink (Dietary Supplement)
Outcomes
Primary Outcomes
Pre/post-intervention change in hsCRP
Time Frame: 6 weeks
Change (reduction) of hsCRP over a 6-week period in older persons.
Secondary Outcomes
- Intestinal permeability(6 weeks)
- Stool: Stool: Real-Time-PCR(6 weeks)
- Blood screening(6 weeks)
- Muscle function(6 weeks)
- Physical performance status(6 weeks)
Investigators
Luzia Valentini
Research Scientist
Charite University, Berlin, Germany