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AgedEarly Phase 1NCT01218165

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

A Early Phase 1 study testing Probiotic drink in people with Aged and Healthy, run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 65 to 85 years, men onlyHealthy volunteers can take part
Conditions the study is for
Aged, Healthy
What is being tested?
Probiotic drink
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteGermany
Study dates
May 2010to May 2011
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 85 years
  • Men only
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charité - Universitätsmedizin Berlin

    Berlin, State of Berlin, 10117

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Conditions
Aged, Healthy
Being tested
Probiotic drink, Control Group
Keywords
Healthy Eldery People

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Probiotic drinkDietary supplement

    This group receives a probiotic drink daily for 6 week.

  • Control GroupOther

    without intervention

Study groups in NCT01218165
Study groupRoleWhat they receive
Control GroupNo interventionwithout intervention
Receives: Other: Control Group
Intervention GroupExperimentalThis group receives a probiotic drink daily for 6 week.
Receives: Dietary Supplement: Probiotic drink

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pre/post-intervention change in hsCRP

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

    Measured: 6 weeks

Secondary outcomes (5)

  1. 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).

    Measured: 6 weeks

  2. Stool: Stool: Real-Time-PCR

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

    Measured: 6 weeks

  3. 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.

    Measured: 6 weeks

  4. 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.

    Measured: 6 weeks

  5. 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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionNov 2010
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01218165
Sponsor's protocol ID
EA1/062/10
Status last verified
Oct 2011
First submitted
8 Oct 2010
Last updated
28 Oct 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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. doi: 10.1016/j.mad.2006.11.016. Epub 2006 Nov 20.

    PubMed 17116321

  • Ballantyne CM, Nambi V. Markers of inflammation and their clinical significance. Atheroscler Suppl. 2005 May;6(2):21-9. doi: 10.1016/j.atherosclerosissup.2005.02.005.

    PubMed 15823493

  • Pearson TA, Mensah GA, Alexander RW, Anderson JL, Cannon RO 3rd, Criqui M, Fadl YY, Fortmann SP, Hong Y, Myers GL, Rifai N, Smith SC Jr, Taubert K, Tracy RP, Vinicor F; Centers for Disease Control and Prevention; American Heart Association. Markers of inflammation and cardiovascular disease: application to clinical and public health practice: A statement for healthcare professionals from the Centers for Disease Control and Prevention and the American Heart Association. Circulation. 2003 Jan 28;107(3):499-511. doi: 10.1161/01.cir.0000052939.59093.45. No abstract available.

    PubMed 12551878

  • Imhof A, Frohlich M, Loewel H, Helbecque N, Woodward M, Amouyel P, Lowe GD, Koenig W. Distributions of C-reactive protein measured by high-sensitivity assays in apparently healthy men and women from different populations in Europe. Clin Chem. 2003 Apr;49(4):669-72. doi: 10.1373/49.4.669. No abstract available.

    PubMed 12651827

  • Lannergard A, Friman G, Ewald U, Lind L, Larsson A. Serum amyloid A (SAA) protein and high-sensitivity C-reactive protein (hsCRP) in healthy newborn infants and healthy young through elderly adults. Acta Paediatr. 2005 Sep;94(9):1198-202. doi: 10.1111/j.1651-2227.2005.tb02074.x.

    PubMed 16279005

  • Libby P, Okamoto Y, Rocha VZ, Folco E. Inflammation in atherosclerosis: transition from theory to practice. Circ J. 2010 Feb;74(2):213-20. doi: 10.1253/circj.cj-09-0706. Epub 2010 Jan 9.

    PubMed 20065609

  • Pradhan AD, Manson JE, Rifai N, Buring JE, Ridker PM. C-reactive protein, interleukin 6, and risk of developing type 2 diabetes mellitus. JAMA. 2001 Jul 18;286(3):327-34. doi: 10.1001/jama.286.3.327.

    PubMed 11466099

  • Griffin WS. Inflammation and neurodegenerative diseases. Am J Clin Nutr. 2006 Feb;83(2):470S-474S. doi: 10.1093/ajcn/83.2.470S.

    PubMed 16470015

  • Kimble RB, Matayoshi AB, Vannice JL, Kung VT, Williams C, Pacifici R. Simultaneous block of interleukin-1 and tumor necrosis factor is required to completely prevent bone loss in the early postovariectomy period. Endocrinology. 1995 Jul;136(7):3054-61. doi: 10.1210/endo.136.7.7789332.

    PubMed 7789332

  • Pirlich M, Norman K, Lochs H, Bauditz J. Role of intestinal function in cachexia. Curr Opin Clin Nutr Metab Care. 2006 Sep;9(5):603-6. doi: 10.1097/01.mco.0000241671.09676.d8.

    PubMed 16912557

  • D'Souza T, Sherman-Baust CA, Poosala S, Mullin JM, Morin PJ. Age-related changes of claudin expression in mouse liver, kidney, and pancreas. J Gerontol A Biol Sci Med Sci. 2009 Nov;64(11):1146-53. doi: 10.1093/gerona/glp118. Epub 2009 Aug 19.

    PubMed 19692671

  • Saltzman JR, Kowdley KV, Perrone G, Russell RM. Changes in small-intestine permeability with aging. J Am Geriatr Soc. 1995 Feb;43(2):160-4. doi: 10.1111/j.1532-5415.1995.tb06382.x.

    PubMed 7836641

  • Beaumont DM, Cobden I, Sheldon WL, Laker MF, James OF. Passive and active carbohydrate absorption by the ageing gut. Age Ageing. 1987 Sep;16(5):294-300. doi: 10.1093/ageing/16.5.294.

    PubMed 3120502

  • Guarner F. Enteric flora in health and disease. Digestion. 2006;73 Suppl 1:5-12. doi: 10.1159/000089775. Epub 2006 Feb 8.

    PubMed 16498248

  • Ordovas JM, Mooser V. Metagenomics: the role of the microbiome in cardiovascular diseases. Curr Opin Lipidol. 2006 Apr;17(2):157-61. doi: 10.1097/01.mol.0000217897.75068.ba.

    PubMed 16531752

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Probiotic drink in people with Aged and Healthy, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pre/post-intervention change in hsCRP (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01218165, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2011.

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