Dietary Modulation of Urinary MCP-1 in ADPKD

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssaf-Harofeh Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥18

Diagnosis of ADPKD based on established clinical or genetic criteria (PKD 1/PKD2)

Estimated glomerular filtration rate (eGFR) between 45 and 90 mL/min/1.73 m²

Mayo Imaging Classification class 1C-1E based on MRI-derived height-adjusted total kidney volume.

Disqualifiers

eGFR <45 mL/min/1.73 m² or requirement for dialysis

History of kidney transplantation

Significant albuminuria, defined as urine albumin to creatinine ratio (UACR) >300 mg/g

Poorly controlled or unstable diabetes mellitus (e.g., HbA1c >8% or clinically significant glycemic variability or frequent hypoglycemia)

Trial design

Treatments tested in this trial

  • Carbohydrate Restricted, Plant Dominant Diet
  • usual diet

Treatment groups

36 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators