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NCT Number: NCT01218165

Low Grade Inflammation, Gut Microbiota and 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.

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Key information

Conditions

Aged Healthy

Age range

65 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

probiotic drink

Dietary Supplement

This group receives a probiotic drink daily for 6 week.

Control Group

Other

without intervention

Primary outcomes

  1. Pre/post-intervention change in hsCRP

    Time frame: 6 weeks

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

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Oct 11, 2010
Registry last updated
Oct 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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