A New Diet for Patients With Autosomal Dominant Polycystic Disease (ADPKD)

Study Overview
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Brief Summary
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Recent evidence has shown that kidney volume predicts the likelihood of developing renal insufficiency over a finite length of time in ADPKD, suggesting a linkage between the growth of cysts and the harm they do to kidney function. Recent studies indicate that the rate of kidney volume increase is hastened by excess dietary protein, salt, and potential net acid precursors, and slowed by increased water intake sufficient to lower plasma vasopressin levels. Diets are commonly prescribed to treat ADPKD and other renal patients with disease near the end-stage, but there is currently no specific diet prescription that takes potentially harmful dietary elements into account for ADPKD patients in the earliest stages of the disease. This study will examine a novel diet for ADPKD created by the researcher termed the ADPKD diet.

Official Title
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A New Diet for Patients With Autosomal Dominant Polycystic Disease (ADPKD)

Conditions
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Autosomal Dominant Polycystic Kidney Disease

Intervention / Treatment
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* Other: ADPKD Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have not been prescribed dietary restrictions or enhancements Blood pressure <135/85 mmHg with or without specific treatment Willingness to participate for at least one month Diet history consistent with the excretion of >30 mEq NAE / day based on usual dietary intake Exclusion Criteria: Other active diseases requiring pharmacologic agents Unstable weight (+/- 2 kg) for 3 months prior to enrollment Food allergies Pregnancy or lactating Confounding medications, i.e. bicarbonate, citrate Individuals who do not consume meat for personal, religious, or health reasons.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADPKD Diet<br>All study participants will follow their regular diet for 8 days. After that, they will be asked to follow the ADPKD diet for a total of 4 weeks. | Other: ADPKD Diet<br>* Diet specifically designed for people with ADPKD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADPKD diet impact on net acid excretion | The difference in net acid excretion from a participants regular diet and the ADPKD diet | Change from Baseline to Day 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance of ADPKD diet | Ease with which diet will be embraced by participants | 36 days | 
| Kidney injury markers | Change in urine markers of renal injury in participants | Change from Baseline to Day 36 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADPKD, PKD, Kidney Disease, ADPKD diet