Clinical trial NCT01810614: A New Diet for Patients With Autosomal Dominant Polycystic Disease (ADPKD)
Official title: A New Diet for Patients With Autosomal Dominant Polycystic Disease (ADPKD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autosomal Dominant Polycystic Kidney Disease
Keywords: ADPKD
PKD
Kidney Disease
ADPKD diet
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: ADPKD diet impact on net acid excretion
timeFrame: Change from Baseline to Day 36
Secondary outcomes:
measure: Acceptance of ADPKD diet
timeFrame: 36 days
measure: Kidney injury markers
timeFrame: Change from Baseline to Day 36
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Debra Sullivan, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.