NCT03959228

Impact of Low Protein Diet Supplemented With Ketoanalogues Supplementation on Uremic Toxins Production

Impact of Low Protein Diet Supplemented With Ketoanalogues on Uremic Toxins Production and Glucose Metabolism in Chronic Kidney Disease

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Chronic kidney disease (CKD) is associated with accumulation of uremic toxins like p-cresyl sulfate and indoxyl sulfate that are associated of cardiovascular complication and perturbation of glucose metabolism. These toxins are produced by fermentation of protein by intestinal microbiota but the role of low protein diet and ketoanalogue supplementation on uremic toxins production and microbiota composition are unknown. Low protein diet supplemented with ketoanalogues is recommended inCKD patients to prevent progression of renal disease. The aim of this study is to determine the impact of uremic toxins concentration, microbiota composition and gut hormone involved in carbohydrate metabolism ( GLP-1, FGF19, bile acids) with low protein diet supplemented with ketoanalogues.

Conditions

• Renal Failure

Interventions

Type	Name	Description
DRUG	keto-analogs	The patients that will be included in the experimental arm will have additional keto-analogs (1 pill/5 kg).

Timeline

• Start date: 2019-11-12
• Primary completion: 2023-12-12
• Completion: 2023-12-12
• First posted: 2019-05-22
• Last updated: 2021-07-09

Locations

1 site across 1 country: France