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Inulin and Protein Fermentation in Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00695513
Recruitment Status : Completed
First Posted : June 12, 2008
Last Update Posted : September 15, 2011
Information provided by (Responsible Party):
Björn Meijers, Universitaire Ziekenhuizen Leuven

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Dietary Supplement: BENEO synergy1 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study on the Effects of BENEO synergy1 on the Generation Rate and Serum Concentration of P-cresol and Related Protein-fermentation Endproducts in Haemodialysis Patients
Study Start Date : March 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: I
BENEO synergy1
Dietary Supplement: BENEO synergy1
50/50 v/v inulin/oligofructose 10 gram BID
Other Names:
  • Synergy1

Primary Outcome Measures :
  1. Decrease p-cresol serum concentration [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00695513

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Universitaire Ziekenhuizen Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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Principal Investigator: Pieter Evenepoel, MD, PhD Universitaire Ziekenhuizen Leuven
Principal Investigator: Bjorn Meijers, MD Universitaire Ziekenhuizen Leuven
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Björn Meijers, Dr., Universitaire Ziekenhuizen Leuven Identifier: NCT00695513    
Other Study ID Numbers: ML3534
First Posted: June 12, 2008    Key Record Dates
Last Update Posted: September 15, 2011
Last Verified: September 2011
Keywords provided by Björn Meijers, Universitaire Ziekenhuizen Leuven:
Food supplement
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency