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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Change in Urinary MCP-1/Creatinine Ratio
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Carbohydrate Restricted, Plant Dominant Diet (Behavioral)
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.
干预措施: usual diet (Behavioral)
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.
干预措施: Carbohydrate Restricted, Plant Dominant Diet (Behavioral)
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.
干预措施: usual diet (Behavioral)
结局指标
主要结局
Change in Urinary MCP-1/Creatinine Ratio
时间窗: 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.
次要结局
- Association Between Carbohydrate Intake and MCP-1(Baseline and End of each 12-week study period (weeks 0,12, 18 and 30))
- Association Between Change in HOMA-IR and MCP-1(Baseline and End of each 12-week study period (weeks 0,12, 18 and 30))
- Dietary Adherence and MCP-1 Response(Baseline and End of each 12-week study period (weeks 0,12, 18 and 30))
- Change in Metabolic and Biochemical Parameters (Safety Outcomes)(Baseline and End of each 12-week study period (weeks 0,12, 18 and 30))
研究者
Elad Nizri
MEDICAL DOCTOR, NEPHROLOGIST
Assaf-Harofeh Medical Center