NCT07651397Not yet recruiting

Dietary Modulation of Urinary MCP-1 in ADPKD

Open Labeled , Randomized, Controlled, Crossover Trial on the Effect of a Carbohydrate Restricted Plant Dominant Diet on MCP-1 Mediated Inflammatory Signaling in Autosomal Dominant Polycystic Kidney Disease

Source: ClinicalTrials.gov · Last updated 26 Jun 2026

Brief summary (registry, in English)

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.

Status (registry): Not yet recruiting
Study type: Interventional
Enrollment: 36 (estimated)
First submitted: 9 Jun 2026
Start date: Jul 2026
Primary completion date: Jan 2029
Lead sponsor: Assaf-Harofeh Medical Center
Diseases: Polycystic kidney disease
NCT number: NCT07651397

What you commit to

Study type: Interventional
Planned participants: 36
From Jul 2026 to the primary completion date, Jan 2029
No sites listed in no country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Current use of systemic corticosteroids or immunosuppressive therapy
Participation in another interventional study within the previous 3 months

Other illness

History of kidney transplantation
Active infection, inflammatory disease, or malignancy that may influence inflammatory markers
Known eating disorder or condition limiting adherence to dietary interventions
Any condition that, in the opinion of the investigators, would interfere with study participation or interpretation of results

Lab values

eGFR \<45 mL/min/1.73 m² or requirement for dialysis
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)
Serum bicarbonate \<20 mmol/L

Other

Use of Tolvaptan at the time of screening or within the study period
Current adherence to a ketogenic or carbohydrate restricted diet
Unintentional weight loss \>5% within the preceding 3 months
Active or symptomatic nephrolithiasis
Pregnancy or breastfeeding

Who the study is looking for

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.
Stable kidney function, defined as no acute kidney injury and no decline in eGFR \>20% within the preceding 3 months
Stable antihypertensive and chronic medications for at least 4 weeks prior to enrollment
Ability and willingness to adhere to the prescribed dietary intervention
Ability to provide written informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.