Dietary Modulation of Urinary MCP-1 in ADPKD
13 czerwca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Szacowany)
36
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: ELAD NIZRI, MD
- Numer telefonu: 972-502932222
- E-mail: nizrielad@gmail.com
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
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.
|
|
Eksperymentalny: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Urinary MCP-1/Creatinine Ratio
Ramy czasowe: Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
|
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)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Association Between Carbohydrate Intake and MCP-1
Ramy czasowe: 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.
|
Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
|
|
Association Between Change in HOMA-IR and MCP-1
Ramy czasowe: Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
|
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.
|
Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
|
|
Dietary Adherence and MCP-1 Response
Ramy czasowe: Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
|
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.
|
Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
|
|
Change in Metabolic and Biochemical Parameters (Safety Outcomes)
Ramy czasowe: Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
|
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.
|
Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Mediation Analysis of Insulin Resistance and MCP-1
Ramy czasowe: Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
|
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.
|
Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
|
|
Gene Expression of CPT1A and ACOX1
Ramy czasowe: Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
|
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.
|
Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
|
|
Exploratory Analysis of the Gut Microbiome
Ramy czasowe: Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
|
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.
|
Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)
|
Współpracownicy i badacze
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Publikacje ogólne
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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
10 lipca 2026
Zakończenie podstawowe (Szacowany)
1 stycznia 2029
Ukończenie studiów (Szacowany)
1 stycznia 2029
Daty rejestracji na studia
Pierwszy przesłany
9 czerwca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
13 czerwca 2026
Pierwszy wysłany (Rzeczywisty)
16 czerwca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
16 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
13 czerwca 2026
Ostatnia weryfikacja
1 kwietnia 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Ciliopatie
- Choroby układu moczowo-płciowego
- Choroby układu moczowo-płciowego u mężczyzn
- Choroby nerek
- Choroby Urologiczne
- Choroby układu moczowo-płciowego kobiet
- Choroby układu moczowo-płciowego kobiet i powikłania ciąży
- Choroby genetyczne, wrodzone
- Wady wrodzone
- Nieprawidłowości, mnogość
- Choroby nerek, torbielowate
- Zespół policystycznych chorób nerek
- Wrodzone, dziedziczne i noworodkowe choroby i nieprawidłowości
- Zespół policystycznych nerek, autosomalny dominujący
Inne numery identyfikacyjne badania
- 0090-26-ASF
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIEZDECYDOWANY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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