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

Early Phase 1

Completed

• Conditions: Aged; Healthy
• Interventions: Other: Control Group; Dietary Supplement: Probiotic drink

• Registration Number: NCT01218165
• Lead Sponsor: Charite University, Berlin, Germany

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 Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-11
• Primary Completion: 2010-11
• Study Completion: 2011-05
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-27
• Last Update Posted: 2011-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Control Group	without intervention
Intervention Group	Probiotic drink	This group receives a probiotic drink daily for 6 week.

Primary Outcome Measures

Name	Time	Method
Pre/post-intervention change in hsCRP	6 weeks	Change (reduction) of hsCRP over a 6-week period in older persons.

Secondary Outcome Measures

Name	Time	Method
Intestinal permeability	6 weeks	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).
Stool: Stool: Real-Time-PCR	6 weeks	During screening and post intervention quantitative Real-Time-PCR of bacterial 16S ribosomal RNA from feces will be performed.
Blood screening	6 weeks	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.
Muscle function	6 weeks	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.
Physical performance status	6 weeks	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.

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany