Low Grade Inflammation, Gut Microbiota and Barrier Function in Elderly Humans

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Inflammaging Network: Bridging Low Grade Inflammation With Gut Microbiota and Intestinal Barrier Function in Elderly Humans

Conditions
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Aged, Healthy

Intervention / Treatment
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* Dietary Supplement: Probiotic drink
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>without intervention | Other: Control Group<br>* without intervention<br>|
| Experimental: Intervention Group<br>This group receives a probiotic drink daily for 6 week. | Dietary Supplement: Probiotic drink<br>* This group receives a probiotic drink daily for 6 week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre/post-intervention change in hsCRP | Change (reduction) of hsCRP over a 6-week period in older persons. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal permeability | Intestinal permeability tests will be performed with a triple sugar test (5 g LAC, 10 g MAN, and 20 g SAC dissolved in 100 ml of water). | 6 weeks | 
| Stool: Stool: Real-Time-PCR | During screening and post intervention quantitative Real-Time-PCR of bacterial 16S ribosomal RNA from feces will be performed. | 6 weeks | 
| Blood screening | Day 0 - Screening: hsCRP, leukocytes, erythrocytes, haemoglobin, haematokrit, sodium, potassium, glucose, total cholesterol, HDL, LDL, bilirubin total, bilirubin direct, ASAT, ALAT, creatinine Day 42 - post intervention: hsCRP, leukocytes, erythrocytes, haemoglobin, haematokrit, glucose, total cholesterol, HDL, LDL. | 6 weeks | 
| Muscle function | Handgrip strength will be evaluated using the Jamar vigorimeter (Preston, Jackson, MI 49204, USA) on Day 0 in the screening period and at the end of the intervention trial. | 6 weeks | 
| Physical performance status | The short physical performance battery (SPPB) (24) will be performed at the start and at the end of the intervention trial. SPPB is used to assess lower extremity function. It evaluates balance, gait, strength, and endurance. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Eldery People