Dietary Modulation of Urinary MCP-1 in ADPKD
13 de junio de 2026 actualizado por: Elad Nizri, Assaf-Harofeh Medical Center
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
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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
36
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: ELAD NIZRI, MD
- Número de teléfono: 972-502932222
- Correo electrónico: nizrielad@gmail.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Sequence A: Dietary Intervention → Usual Diet
Participants receive a carbohydrate restricted, plant dominant diet for 12 weeks, followed by a washout period and then usual diet for 12 weeks.
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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.
Participants continue their habitual diet without specific dietary intervention or structured nutritional guidance.
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Experimental: Sequence B: Usual Diet → Dietary Intervention
Participants follow their usual diet for 12 weeks, followed by a washout period and then the dietary intervention for 12 weeks.
|
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.
Participants continue their habitual diet without specific dietary intervention or structured nutritional guidance.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Urinary MCP-1/Creatinine Ratio
Periodo de tiempo: Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
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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.
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Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Association Between Carbohydrate Intake and MCP-1
Periodo de tiempo: Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
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Mean carbohydrate intake during each study period will be calculated from repeated dietary assessments.
The association between carbohydrate intake and urinary MCP-1/creatinine ratio will be evaluated to explore a potential dose response relationship.
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Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
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Association Between Change in HOMA-IR and MCP-1
Periodo de tiempo: Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
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The association between changes in insulin resistance (HOMA-IR) and changes in urinary MCP-1/creatinine ratio will be evaluated within individuals across study conditions.
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Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
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Dietary Adherence and MCP-1 Response
Periodo de tiempo: Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
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Dietary adherence will be defined as the proportion of dietary assessments in which carbohydrate intake falls within the target range (15-25% of total energy intake).
The association between adherence and urinary MCP-1/creatinine ratio will be evaluated.
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Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
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Change in Metabolic and Biochemical Parameters (Safety Outcomes)
Periodo de tiempo: Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
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Changes in selected metabolic and biochemical parameters, including serum bicarbonate, LDL cholesterol, and estimated glomerular filtration rate (eGFR), will be assessed between study conditions to evaluate the safety of the dietary intervention.
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Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mediation Analysis of Insulin Resistance and MCP-1
Periodo de tiempo: Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
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Exploratory analysis to evaluate whether changes in insulin resistance (HOMA-IR) mediate the relationship between dietary intervention and urinary MCP-1/creatinine ratio using regression based mediation models.
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Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
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Gene Expression of CPT1A and ACOX1
Periodo de tiempo: Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
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Pre-specified exploratory analysis of gene expression of CPT1A and ACOX1, key regulators of fatty acid oxidation pathways, measured in peripheral blood samples.
Expression levels will be evaluated in relation to dietary intervention and changes in urinary MCP-1/creatinine ratio.
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Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
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Exploratory Analysis of the Gut Microbiome
Periodo de tiempo: Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
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Exploratory analyses will evaluate changes in gut microbial composition associated with the dietary intervention.
Stool samples collected at baseline and at the end of each study period will undergo microbiome analysis.
Changes in microbial diversity and taxonomic composition will be explored and correlated with dietary adherence, urinary MCP-1 levels, and metabolic parameters.
Given the exploratory nature of these analyses and the limited sample size, findings will be considered hypothesis-generating.
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Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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- Torres JA, Kruger SL, Broderick C, Amarlkhagva T, Agrawal S, Dodam JR, Mrug M, Lyons LA, Weimbs T. Ketosis Ameliorates Renal Cyst Growth in Polycystic Kidney Disease. Cell Metab. 2019 Dec 3;30(6):1007-1023.e5. doi: 10.1016/j.cmet.2019.09.012. Epub 2019 Oct 17.
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- Kim H, Caulfield LE, Garcia-Larsen V, Steffen LM, Grams ME, Coresh J, Rebholz CM. Plant-Based Diets and Incident CKD and Kidney Function. Clin J Am Soc Nephrol. 2019 May 7;14(5):682-691. doi: 10.2215/CJN.12391018. Epub 2019 Apr 25.
- D'Alessandro C, Torreggiani M, Lippi F, Avesani C, Cupisti A, Piccoli GB. A Requiem for a Standardized Calculation of Ideal Body Weight in Chronic Kidney Disease? J Ren Nutr. 2026 Jan 15:S1051-2276(26)00006-3. doi: 10.1053/j.jrn.2025.12.007. Online ahead of print.
- Ryu H, Park HC, Kim H, Heo J, Kang E, Hwang YH, Cho JY, Lee KB, Oh YK, Oh KH, Ahn C. Bioelectrical impedance analysis as a nutritional assessment tool in Autosomal Dominant Polycystic Kidney Disease. PLoS One. 2019 Apr 4;14(4):e0214912. doi: 10.1371/journal.pone.0214912. eCollection 2019.
- Charles K, Lewis MJ, Montgomery E, Reid M. The 2021 Chronic Kidney Disease Epidemiology Collaboration Race-Free Estimated Glomerular Filtration Rate Equations in Kidney Disease: Leading the Way in Ending Disparities. Health Equity. 2024 Jan 12;8(1):39-45. doi: 10.1089/heq.2023.0038. eCollection 2024.
- Ludwig DS, Willett WC, Putt ME. Wash-in and washout effects: mitigating bias in short term dietary and other trials. BMJ. 2025 Apr 22;389:e082963. doi: 10.1136/bmj-2024-082963.
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Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
10 de julio de 2026
Finalización primaria (Estimado)
1 de enero de 2029
Finalización del estudio (Estimado)
1 de enero de 2029
Fechas de registro del estudio
Enviado por primera vez
9 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
13 de junio de 2026
Publicado por primera vez (Actual)
16 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
13 de junio de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Ciliopatías
- Enfermedades urogenitales
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades Genéticas Congénitas
- Anomalías congénitas
- Anomalías Múltiples
- Enfermedades Renales Quísticas
- Enfermedades renales poliquísticas
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Riñón Poliquístico, Autosómico Dominante
Otros números de identificación del estudio
- 0090-26-ASF
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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