A New Diet for Patients With Autosomal Dominant Polycystic Disease (ADPKD)
Primary Purpose
Autosomal Dominant Polycystic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ADPKD Diet
Sponsored by
About this trial
This is an interventional prevention trial for Autosomal Dominant Polycystic Kidney Disease focused on measuring ADPKD, PKD, Kidney Disease, 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.
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ADPKD Diet
Arm Description
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.
Outcomes
Primary Outcome Measures
ADPKD diet impact on net acid excretion
The difference in net acid excretion from a participants regular diet and the ADPKD diet
Secondary Outcome Measures
Acceptance of ADPKD diet
Ease with which diet will be embraced by participants
Kidney injury markers
Change in urine markers of renal injury in participants
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01810614
Brief Title
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
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autosomal Dominant Polycystic Kidney Disease
Keywords
ADPKD, PKD, Kidney Disease, ADPKD diet
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ADPKD Diet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
ADPKD Diet
Intervention Description
Diet specifically designed for people with ADPKD
Primary Outcome Measure Information:
Title
ADPKD diet impact on net acid excretion
Description
The difference in net acid excretion from a participants regular diet and the ADPKD diet
Time Frame
Change from Baseline to Day 36
Secondary Outcome Measure Information:
Title
Acceptance of ADPKD diet
Description
Ease with which diet will be embraced by participants
Time Frame
36 days
Title
Kidney injury markers
Description
Change in urine markers of renal injury in participants
Time Frame
Change from Baseline to Day 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra Sullivan, PhD, RD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27537328
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.
Results Reference
derived
PubMed Identifier
26811129
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.
Results Reference
derived
Learn more about this trial
A New Diet for Patients With Autosomal Dominant Polycystic Disease (ADPKD)
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