Clinical Trial

Dietary Modulation of Urinary MCP-1 in ADPKD

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Summary
Autosomal dominant polycystic kidney disease (ADPKD) is characterized by progressive cyst growth and declining kidney function. Inflammatory pathways, including those mediated by monocyte chemoattractant protein-1 (MCP-1), are increasingly recognized as contributors to disease progression. Metabolic alterations in cystic epithelial cells may influence inflammatory signaling, suggesting a potential role for dietary interventions targeting metabolic pathways. This study is a prospective, randomized, open-label crossover trial designed to evaluate the effect of a carbohydrate restricted, plant dominant dietary intervention on urinary MCP-1 levels in adults with ADPKD. Participants will be randomized to one of two sequences: dietary intervention followed by usual diet, or usual diet followed by dietary intervention, with a washout period between study phases. Each study period will last 12 weeks. The primary objective is to assess within subject differences in urinary MCP-1/creatinine ratio between the dietary intervention and usual diet conditions. Secondary outcomes include measures of metabolic parameters, insulin resistance, dietary adherence, and safety. This study aims to explore whether a structured dietary approach may influence intrarenal inflammatory activity in ADPKD and provide preliminary data to inform future interventional studies.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-06-13.
Trial Details
NCT Number NCT07651397
Lead Sponsor Assaf-Harofeh Medical Center
Conditions Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Enrollment 36 participants
Start Date 2026-07-10
Primary Completion 2029-01-01 (estimated)
Study Completion 2029-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-26