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Dietary Modulation of Urinary MCP-1 in ADPKD

13. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

36

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  1. Age ≥18
  2. Diagnosis of ADPKD based on established clinical or genetic criteria (PKD 1/PKD2)
  3. Estimated glomerular filtration rate (eGFR) between 45 and 90 mL/min/1.73 m²
  4. Mayo Imaging Classification class 1C-1E based on MRI-derived height-adjusted total kidney volume.
  5. Stable kidney function, defined as no acute kidney injury and no decline in eGFR >20% within the preceding 3 months
  6. Stable antihypertensive and chronic medications for at least 4 weeks prior to enrollment
  7. Ability and willingness to adhere to the prescribed dietary intervention
  8. Ability to provide written informed consent

Exclusion Criteria:

  1. eGFR <45 mL/min/1.73 m² or requirement for dialysis
  2. History of kidney transplantation
  3. Significant albuminuria, defined as urine albumin to creatinine ratio (UACR) >300 mg/g
  4. Poorly controlled or unstable diabetes mellitus (e.g., HbA1c >8% or clinically significant glycemic variability or frequent hypoglycemia)
  5. Use of Tolvaptan at the time of screening or within the study period
  6. Current adherence to a ketogenic or carbohydrate restricted diet
  7. Unintentional weight loss >5% within the preceding 3 months
  8. Active infection, inflammatory disease, or malignancy that may influence inflammatory markers
  9. Current use of systemic corticosteroids or immunosuppressive therapy
  10. Active or symptomatic nephrolithiasis
  11. Serum bicarbonate <20 mmol/L
  12. Pregnancy or breastfeeding
  13. Known eating disorder or condition limiting adherence to dietary interventions
  14. Participation in another interventional study within the previous 3 months
  15. Any condition that, in the opinion of the investigators, would interfere with study participation or interpretation of results

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verhalten: Carbohydrate Restricted, Plant Dominant Diet
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.
Verhalten: usual diet
Participants continue their habitual diet without specific dietary intervention or structured nutritional guidance.
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.
Verhalten: Carbohydrate Restricted, Plant Dominant Diet
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.
Verhalten: usual diet
Participants continue their habitual diet without specific dietary intervention or structured nutritional guidance.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Urinary MCP-1/Creatinine Ratio
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Association Between Carbohydrate Intake and MCP-1
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mediation Analysis of Insulin Resistance and MCP-1
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Assaf-Harofeh Medical Center

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

10. Juli 2026

Primärer Abschluss (Geschätzt)

1. Januar 2029

Studienabschluss (Geschätzt)

1. Januar 2029

Studienanmeldedaten

Zuerst eingereicht

9. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Juni 2026

Zuerst gepostet (Tatsächlich)

16. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Juni 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 0090-26-ASF

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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