Dietary Modulation of Urinary MCP-1 in ADPKD
13 de junho de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
36
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: ELAD NIZRI, MD
- Número de telefone: 972-502932222
- E-mail: nizrielad@gmail.com
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Urinary MCP-1/Creatinine Ratio
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Association Between Carbohydrate Intake and MCP-1
Prazo: Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
|
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
Prazo: 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
Prazo: 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)
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mediation Analysis of Insulin Resistance and MCP-1
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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Publicações Gerais
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
10 de julho de 2026
Conclusão Primária (Estimado)
1 de janeiro de 2029
Conclusão do estudo (Estimado)
1 de janeiro de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
9 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de junho de 2026
Primeira postagem (Real)
16 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
13 de junho de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Ciliopatias
- Doenças urogenitais
- Doenças Urogenitais Masculinas
- Doenças renais
- Doenças Urológicas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Doenças Genéticas, Congênitas
- Anomalias congénitas
- Anormalidades, Múltiplas
- Doenças Renais Císticas
- Doenças Renais Policísticas
- Doenças e Anormalidades Congênitas, Hereditárias e Neonatais
- Rim Policístico, Autossômico Dominante
Outros números de identificação do estudo
- 0090-26-ASF
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .