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

NCT ID: NCT01810614

Last Updated: 2015-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-11-30

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.

Conditions

Autosomal Dominant Polycystic Kidney Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ADPKD Diet

Intervention Type: OTHER

Diet specifically designed for people with ADPKD

Interventions

ADPKD Diet

Diet specifically designed for people with ADPKD

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Debra Sullivan, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27537328 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26811129 (View on PubMed)

Other Identifiers

13493

Identifier Type: -

Identifier Source: org_study_id