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

Primary Purpose

Aged, Healthy

Status
Completed
Phase
Early Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Probiotic drink
Control Group
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aged focused on measuring Healthy Eldery People

Eligibility Criteria

65 Years - 85 Years (Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Charité - Universitätsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Intervention Group

Arm Description

without intervention

This group receives a probiotic drink daily for 6 week.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
Stool: Stool: Real-Time-PCR
During screening and post intervention quantitative Real-Time-PCR of bacterial 16S ribosomal RNA from feces will be performed.
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.
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.
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.

Full Information

First Posted
October 8, 2010
Last Updated
October 27, 2011
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01218165
Brief Title
Low Grade Inflammation, Gut Microbiota and Barrier Function in Elderly Humans
Official Title
The Inflammaging Network: Bridging Low Grade Inflammation With Gut Microbiota and Intestinal Barrier Function in Elderly Humans
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aged, Healthy
Keywords
Healthy Eldery People

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
without intervention
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
This group receives a probiotic drink daily for 6 week.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic drink
Intervention Description
This group receives a probiotic drink daily for 6 week.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
without intervention
Primary Outcome Measure Information:
Title
Pre/post-intervention change in hsCRP
Description
Change (reduction) of hsCRP over a 6-week period in older persons.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Intestinal permeability
Description
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).
Time Frame
6 weeks
Title
Stool: Stool: Real-Time-PCR
Description
During screening and post intervention quantitative Real-Time-PCR of bacterial 16S ribosomal RNA from feces will be performed.
Time Frame
6 weeks
Title
Blood screening
Description
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.
Time Frame
6 weeks
Title
Muscle function
Description
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.
Time Frame
6 weeks
Title
Physical performance status
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luzia Valentini, Doctor
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Herbert Lochs, Professor
Organizational Affiliation
Medical University of Innsbruck
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jörg-Dieter Schulzke, Professor
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefan Bereswill, Professor
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Swidsinski, Doctor
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

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

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