An interventional study of Arabinoxylan-oligosaccharides and Maltodextrine in Chronic Kidney Disease, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-04-27.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Treatment
Chronic kidney disease is associated with the accumulation of various metabolites, i.e., uremic retention solutes. Evidence is mounting that the colonic microbiota contributes substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are among the most extensively studied gut microbial metabolites, and are associated with cardiovascular disease, overall mortality and chronic kidney disease progression. The most important regulator of colonic bacterial metabolism is nutrient availability and especially the ratio of available fermentable carbohydrate to nitrogen, which can be modified by intake of so-called prebiotics (non-digestible food ingredients). Arabinoxylan oligosaccharides (AXOS) are a recently developed group of prebiotics, and already demonstrated a decreasing effect on intestinal generation of p-cresol in healthy individuals. Whether prebiotics in general, and AXOS more specifically, can influence intestinal generation of microbial metabolites in predialysis patients has not been studied to date. An interventional study with AXOS will therefore be initiated to test the hypothesis that AXOS can decrease intestinal generation and serum concentrations of microbial metabolites in patients with CKD not yet on dialysis.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 40 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
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Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Arabinoxylan-oligosaccharides 10g BID
Dietary Supplement: Arabinoxylan-oligosaccharides
Maltodextrine BID
Dietary Supplement: Maltodextrine
Also known as: AXOS
Serum levels of p-cresol and indole derivatives
Time frame: After 4 weeks of intervention
Urinary excretion rates of p-cresol and indole derivatives
Time frame: After 4 weeks of intervention
Insuline resistance
Insuline resistance, measured by HOMA index
Time frame: After 4 weeks of intervention
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Universitaire Ziekenhuizen KU Leuven