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Dietary Modulation of Urinary MCP-1 in ADPKD

2026年6月13日 更新者: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.

調査の概要

研究の種類

介入

入学 (推定)

36

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:基礎科学
  • 割り当て:ランダム化
  • 介入モデル:クロスオーバー割り当て
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Urinary MCP-1/Creatinine Ratio
時間枠: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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Association Between Carbohydrate Intake and MCP-1
時間枠: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
時間枠: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
時間枠: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)
時間枠: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)

その他の成果指標

結果測定
メジャーの説明
時間枠
Mediation Analysis of Insulin Resistance and MCP-1
時間枠: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
時間枠: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
時間枠: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)

協力者と研究者

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出版物と役立つリンク

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一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月10日

一次修了 (推定)

2029年1月1日

研究の完了 (推定)

2029年1月1日

試験登録日

最初に提出

2026年6月9日

QC基準を満たした最初の提出物

2026年6月13日

最初の投稿 (実際)

2026年6月16日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月16日

QC基準を満たした最後の更新が送信されました

2026年6月13日

最終確認日

2026年4月1日

詳しくは

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個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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