Dietary Modulation of Urinary MCP-1 in ADPKD

NCT07651397 | Not Yet Recruiting

• 1 other identifier: 0090-26-ASF
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Outcome Measures

Primary Outcomes (1)

• Change in Urinary MCP-1/Creatinine Ratio

  Urinary MCP-1 levels will be measured in first morning urine samples and normalized to urine creatinine (MCP-1/creatinine ratio). For each study period, two samples will be collected within the final week (2-5 days apart), and the mean value will be used. The primary outcome is the within subject difference in MCP-1/creatinine ratio between the dietary intervention and usual diet conditions.

  Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)

Secondary Outcomes (4)

• Association Between Carbohydrate Intake and MCP-1

  Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)

• Association Between Change in HOMA-IR and MCP-1

  Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)

• Dietary Adherence and MCP-1 Response

  Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)

• Change in Metabolic and Biochemical Parameters (Safety Outcomes)

  Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)

Other Outcomes (4)

• Mediation Analysis of Insulin Resistance and MCP-1

  Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)

• Gene Expression of CPT1A and ACOX1

  Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)

• Exploratory Analysis of the Gut Microbiome

  Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)

Study Arms (2)

Sequence A: Dietary Intervention → Usual Diet

EXPERIMENTAL

Participants receive a carbohydrate restricted, plant dominant diet for 12 weeks, followed by a washout period and then usual diet for 12 weeks.

Behavioral: Carbohydrate Restricted, Plant Dominant Diet; Behavioral: usual diet

Sequence B: Usual Diet → Dietary Intervention

EXPERIMENTAL

Participants follow their usual diet for 12 weeks, followed by a washout period and then the dietary intervention for 12 weeks.

Behavioral: Carbohydrate Restricted, Plant Dominant Diet; Behavioral: usual diet

Interventions

Carbohydrate Restricted, Plant Dominant Diet BEHAVIORAL

A structured dietary intervention targeting approximately 20% of total daily energy intake from carbohydrates (range 15-25%), with a plant dominant composition. Energy and protein intake are prescribed based on adjusted body weight. The intervention is not ketogenic and is not intended to induce nutritional ketosis. Participants receive individualized dietary counseling and ongoing support from a registered dietitian.

Sequence A: Dietary Intervention → Usual Diet; Sequence B: Usual Diet → Dietary Intervention

usual diet BEHAVIORAL

Participants continue their habitual diet without specific dietary intervention or structured nutritional guidance.

Sequence A: Dietary Intervention → Usual Diet; Sequence B: Usual Diet → Dietary Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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 infection, inflammatory disease, or malignancy that may influence inflammatory markers
• Current use of systemic corticosteroids or immunosuppressive therapy
• Active or symptomatic nephrolithiasis
• Serum bicarbonate \<20 mmol/L
• Pregnancy or breastfeeding
• Known eating disorder or condition limiting adherence to dietary interventions
• Participation in another interventional study within the previous 3 months
• Any condition that, in the opinion of the investigators, would interfere with study participation or interpretation of results

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

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MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Central Study Contacts

ELAD NIZRI, MD

CONTACT

972-502932222; nizrielad@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MEDICAL DOCTOR, NEPHROLOGIST

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 16, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: June 26, 2026

Record last verified: 2026-04