Inulin and Protein Fermentation in Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Björn Meijers, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT00695513
First received: June 10, 2008
Last updated: September 14, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Chronic Kidney Disease
Dietary Supplement: BENEO synergy1
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Decrease p-cresol serum concentration [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decreased generation rate of p-cresol [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Decreased serum concentration of related uremic retention solutes [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in bowel habits as measured by validated constipation scores [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • inflammation (c-reactive protein) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 22
Study Start Date: March 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
BENEO synergy1
Dietary Supplement: BENEO synergy1
50/50 v/v inulin/oligofructose 10 gram BID
Other Names:
  • BENEO
  • Synergy1

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695513

Locations
Belgium
Universitaire Ziekenhuizen Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Pieter Evenepoel, MD, PhD University Hospitals Leuven
Principal Investigator: Bjorn Meijers, MD University Hospitals Leuven
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Björn Meijers, Dr., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT00695513     History of Changes
Other Study ID Numbers: ML3534
Study First Received: June 10, 2008
Last Updated: September 14, 2011
Health Authority: Belgium: Institutional Review Board

Keywords provided by Universitaire Ziekenhuizen Leuven:
Food supplement
Haemodialysis

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on September 22, 2014