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

NCT01218165 | Completed Early Phase 1

• 1 other identifier: EA1/062/10
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Aged; Healthy

Keywords

Healthy Eldery People

Outcome Measures

Primary Outcomes (1)

• Pre/post-intervention change in hsCRP

  Change (reduction) of hsCRP over a 6-week period in older persons.

  6 weeks

Secondary Outcomes (5)

• Intestinal permeability

  6 weeks

• Stool: Stool: Real-Time-PCR

  6 weeks

• Blood screening

  6 weeks

• Muscle function

  6 weeks

• Physical performance status

  6 weeks

Study Arms (2)

Control Group

NO INTERVENTION

without intervention

Other: Control Group

Intervention Group

EXPERIMENTAL

This group receives a probiotic drink daily for 6 week.

Dietary Supplement: Probiotic drink

Interventions

Probiotic drink DIETARY_SUPPLEMENT

This group receives a probiotic drink daily for 6 week.

Intervention Group

Control Group OTHER

without intervention

Control Group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (24)

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MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Luzia Valentini, Doctor

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Herbert Lochs, Professor

  Medical University of Innsbruck

  PRINCIPAL INVESTIGATOR

• Jörg-Dieter Schulzke, Professor

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Stefan Bereswill, Professor

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Alexander Swidsinski, Doctor

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: October 11, 2010
• Study Start: May 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: May 1, 2011
• Last Updated: October 28, 2011

Record last verified: 2011-10

Locations

DE (1)