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

Not Applicable

Completed

• Conditions: Autosomal Dominant Polycystic Kidney Disease
• Interventions: Other: ADPKD Diet

• Registration Number: NCT01810614
• Lead Sponsor: University of Kansas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-03-11
• Study First Posted: 2013-03-13
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-11
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ADPKD Diet	ADPKD Diet	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.

Primary Outcome Measures

Name	Time	Method
ADPKD diet impact on net acid excretion	Change from Baseline to Day 36	The difference in net acid excretion from a participants regular diet and the ADPKD diet

Secondary Outcome Measures

Name	Time	Method
Acceptance of ADPKD diet	36 days	Ease with which diet will be embraced by participants
Kidney injury markers	Change from Baseline to Day 36	Change in urine markers of renal injury in participants

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States