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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01218165
• Other study ID #: EA1/062/10
• Status: Completed
• Phase: Phase 0
• First received: October 8, 2010
• Last updated: October 27, 2011
• Start date: May 2010
• Est. completion date: May 2011

Study information

• Verified date: October 2011
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institution for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 65 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aged
• Healthy

Intervention

Dietary Supplement:
• Probiotic drink
This group receives a probiotic drink daily for 6 week.

Other:
• Control Group
without intervention

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (24)

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Franceschi C, Capri M, Monti D, Giunta S, Olivieri F, Sevini F, Panourgia MP, Invidia L, Celani L, Scurti M, Cevenini E, Castellani GC, Salvioli S. Inflammaging and anti-inflammaging: a systemic perspective on aging and longevity emerged from studies in humans. Mech Ageing Dev. 2007 Jan;128(1):92-105. Epub 2006 Nov 20. Review. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre/post-intervention change in hsCRP	Change (reduction) of hsCRP over a 6-week period in older persons.	6 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No