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

October 27, 2011 updated by: Luzia Valentini, Charite University, Berlin, Germany

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control Group
without intervention
Other: Control Group
without intervention
EXPERIMENTAL: Intervention Group
This group receives a probiotic drink daily for 6 week.
Dietary supplement: Probiotic drink
This group receives a probiotic drink daily for 6 week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre/post-intervention change in hsCRP
Time Frame: 6 weeks
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
Time Frame: 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).
6 weeks
Stool: Stool: Real-Time-PCR
Time Frame: 6 weeks
During screening and post intervention quantitative Real-Time-PCR of bacterial 16S ribosomal RNA from feces will be performed.
6 weeks
Blood screening
Time Frame: 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.
6 weeks
Muscle function
Time Frame: 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.
6 weeks
Physical performance status
Time Frame: 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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

October 8, 2010

First Submitted That Met QC Criteria

October 8, 2010

First Posted (ESTIMATE)

October 11, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 28, 2011

Last Update Submitted That Met QC Criteria

October 27, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA1/062/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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