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