Dietary Modulation of Urinary MCP-1 in ADPKD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssaf-Harofeh Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Crossover
Treatments tested in this trial
Carbohydrate Restricted, Plant Dominant Diet
BehavioralA 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.
usual diet
BehavioralParticipants continue their habitual diet without specific dietary intervention or structured nutritional guidance.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Sequence A: Dietary Intervention → Usual DietExperimental treatment 2 interventions
Group B: Sequence B: Usual Diet → Dietary InterventionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in Urinary MCP-1/Creatinine Ratio
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.
Time frame
Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)Secondary outcomes
1
Association Between Carbohydrate Intake and MCP-1
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.
Time frame
Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)2
Association Between Change in HOMA-IR and MCP-1
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.
Time frame
Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)3
Dietary Adherence and MCP-1 Response
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.
Time frame
Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)4
Change in Metabolic and Biochemical Parameters (Safety Outcomes)
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.
Time frame
Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)Other outcomes
1
Mediation Analysis of Insulin Resistance and MCP-1
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.
Time frame
Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)2
Gene Expression of CPT1A and ACOX1
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.
Time frame
Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)3
Exploratory Analysis of the Gut Microbiome
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.
Time frame
Baseline and End of each 12-week study period (weeks 0,12, 18 and 30)4
Health-Related Quality of Life (SF-36)
Pre-specified exploratory assessment of health-related quality of life using the Short Form-36 (SF-36) questionnaire.
Time frame
Baseline and end of each 12-week study period (Weeks 0, 12, 18, and 30)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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