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CompletedNCT00695513Updated Sep 15, 2011

Inulin and Protein Fermentation in Hemodialysis Patients

A Phase 1/2 interventional study of BENEO synergy1 in Chronic Kidney Disease, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-15.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

An important group of protein-bound uremic retention solutes originate from protein fermentation in the colon. P-cresol is a putrefaction metabolite of tyrosine. Indole is generated by fermentation of tryptophan. After absorption, the majority of p-cresol and indole are further metabolised and conjugated to form p-cresylsulphate and indoxyl sulphate. There is clear evidence, both in vitro and in vivo, that accumulation of these conjugated fermentation metabolites in kidney disease is correlated with clinical (cardiovascular) endpoints.

Bacterial protein fermentation can be influenced by altering the colonic microenvironment, influencing the ratio of available carbohydrates to nitrogen, by shortening the colonic transit time or a combination of these. From a theoretical point of view, functional foods, i.e. pro-, pre- and synbiotics, fulfil these criteria.

Prebiotics have been defined as non-digestible food ingredients that beneficially affect the host by selectively stimulating growth, and/or activity, of one or a restricted number of bacteria in the colon. Dietary fibre may suppress the generation of bacterial protein fermentation either by altering the colonic microenvironment or by shortening the colonic transit time. Animal and clinical studies evaluating the effect of dietary fibre supplements on the generation of bacterial fermentation metabolites have provided conflicting results. These discrepancies may be related to specific properties of the dietary fibre investigated. Dietary fibre may impair protein assimilation and the fermentability may vary to a substantial extent.

Inulin and oligofructose have attracted much attention recently as nonabsorbable carbohydrates with prebiotic properties. When inulin and oligofructose were added to a controlled diet, significant increases were noted in colonic bifidobacterial populations, and it has been proposed that these changes promote both colonic and systemic health through modification of the intestinal microflora. Inulin and oligofructose are rapidly and completely fermented by the colonic microflora with the production of acetate and other short-chain fatty acids. In healthy individuals, supplementation with a mixture of inulin and oligofructose was shown to lower p-cresol generation. Although data in healthy volunteers are promising, no data are available in hemodialysis patients.

02

Conditions studied

  • Chronic Kidney Disease

Keywords

  • Food supplement
  • Haemodialysis
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In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 22 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Chronic hemodialysis patients on maintenance dialysis treatment.
  • 18 years of age or older
  • Written informed consent

Exclusion criteria

Exclusion Criteria:

  • Use of pre-/pro-/syn- or antibiotics in preceding 4 weeks.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (estimated)

Study arms

  • Experimental
    I

    BENEO synergy1

    Dietary Supplement: BENEO synergy1

Interventions

  • Dietary supplementBENEO synergy1

    50/50 v/v inulin/oligofructose 10 gram BID

    Also known as: BENEO, Synergy1

06

What researchers measure

Primary outcomes

  1. Decrease p-cresol serum concentration

    Time frame: 4 weeks

Secondary outcomes

  1. Decreased generation rate of p-cresol

    Time frame: 4 weeks

  2. Decreased serum concentration of related uremic retention solutes

    Time frame: 4 weeks

  3. Change in bowel habits as measured by validated constipation scores

    Time frame: 4 weeks

  4. inflammation (c-reactive protein)

    Time frame: 4 weeks

07

Study locations

1 site
  • Universitaire Ziekenhuizen Leuven
    Leuven, Vlaams-Brabant 3000, Belgium
08

References and documents

Publications

  • Meijers BK, Bammens B, De Moor B, Verbeke K, Vanrenterghem Y, Evenepoel P. Free p-cresol is associated with cardiovascular disease in hemodialysis patients. Kidney Int. 2008 May;73(10):1174-80. doi: 10.1038/ki.2008.31. Epub 2008 Feb 27. PubMed 18305466 ↗
  • De Preter V, Vanhoutte T, Huys G, Swings J, De Vuyst L, Rutgeerts P, Verbeke K. Effects of Lactobacillus casei Shirota, Bifidobacterium breve, and oligofructose-enriched inulin on colonic nitrogen-protein metabolism in healthy humans. Am J Physiol Gastrointest Liver Physiol. 2007 Jan;292(1):G358-68. doi: 10.1152/ajpgi.00052.2006. Epub 2006 Sep 21. PubMed 16990449 ↗
  • Meijers BK, De Preter V, Verbeke K, Vanrenterghem Y, Evenepoel P. p-Cresyl sulfate serum concentrations in haemodialysis patients are reduced by the prebiotic oligofructose-enriched inulin. Nephrol Dial Transplant. 2010 Jan;25(1):219-24. doi: 10.1093/ndt/gfp414. Epub 2009 Aug 19. PubMed 19692415 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00695513
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Björn Meijers (Dr., Universitaire Ziekenhuizen KU Leuven) — Principal investigator
First posted
Jun 12, 2008
Start date
Mar 2006
Primary completion
Jul 2008
Completion
Jul 2008
Last update
Sep 15, 2011

Study contacts

Pieter Evenepoel, MD, PhD
principal investigator · Universitaire Ziekenhuizen KU Leuven
Bjorn Meijers, MD
principal investigator · Universitaire Ziekenhuizen KU Leuven

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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