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

August 11, 2015 updated by: University of Kansas

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from Baseline to Day 36

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

March 11, 2013

First Submitted That Met QC Criteria

March 11, 2013

First Posted (Estimate)

March 13, 2013

Study Record Updates

Last Update Posted (Estimate)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 11, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13493

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autosomal Dominant Polycystic Kidney Disease

Clinical Trials on ADPKD Diet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe