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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Autosomal Dominant Polycystic Kidney Disease	Other: ADPKD Diet	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	12 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	A New Diet for Patients With Autosomal Dominant Polycystic Disease (ADPKD)
Study Start Date :	February 2013
Actual Primary Completion Date :	November 2014
Actual Study Completion Date :	November 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 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.	Other: ADPKD Diet; Diet specifically designed for people with ADPKD

Outcome Measures

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Primary Outcome Measures :

1. ADPKD diet impact on net acid excretion [ Time Frame: Change from Baseline to Day 36 ]
   The difference in net acid excretion from a participants regular diet and the ADPKD diet

Secondary Outcome Measures :

1. Acceptance of ADPKD diet [ Time Frame: 36 days ]
   Ease with which diet will be embraced by participants
2. Kidney injury markers [ Time Frame: Change from Baseline to Day 36 ]
   Change in urine markers of renal injury in participants

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Locations

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160

Sponsors and Collaborators

University of Kansas

Investigators

Principal Investigator:	Debra Sullivan, PhD, RD	University of Kansas Medical Center

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Taylor JM, Ptomey L, Hamilton-Reeves JM, Sullivan DK, Creed C, Carlson SE, Wesson DE, Grantham JJ, Gibson CA. Experiences and Perspectives of Polycystic Kidney Disease Patients following a Diet of Reduced Osmoles, Protein, and Acid Precursors Supplemented with Water: A Qualitative Study. PLoS One. 2016 Aug 18;11(8):e0161043. doi: 10.1371/journal.pone.0161043. eCollection 2016.

Taylor JM, Hamilton-Reeves JM, Sullivan DK, Gibson CA, Creed C, Carlson SE, Wesson DE, Grantham JJ. Diet and polycystic kidney disease: A pilot intervention study. Clin Nutr. 2017 Apr;36(2):458-466. doi: 10.1016/j.clnu.2016.01.003. Epub 2016 Jan 11.

Responsible Party:	University of Kansas
ClinicalTrials.gov Identifier:	NCT01810614 History of Changes
Other Study ID Numbers:	13493
First Posted:	March 13, 2013
Last Update Posted:	August 13, 2015
Last Verified:	August 2015

Keywords provided by University of Kansas Medical Center ( University of Kansas ):

ADPKD; PKD; Kidney Disease; ADPKD diet

Additional relevant MeSH terms:

Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant; Urologic Diseases	Kidney Diseases, Cystic; Abnormalities, Multiple; Congenital Abnormalities; Genetic Diseases, Inborn