Pilot Study of Taste Sensations in Patients With End-stage Renal Disease on Hemodialysis

April 16, 2018 updated by: Kathleen Hill Gallant, Purdue University
Individuals on dialysis due to kidney failure have very prescriptive diets. These diets help increase dialysis effectiveness and help patients control blood levels of electrolytes including potassium and phosphate, acid-base balance, blood pressure, and fluid between dialysis treatments. However, patient compliance with these diets often can be very low, and one reason for this low compliance is disguesia (abnormal taste sensations) which can make the diets unpalatable. This experiment tests the hypothesis that disguesia, and subsequent lack of adherence to a dialysis friendly diet, is a result of either vascular taste (tasting your own blood through the basolateral side of taste cells) or altered chemical composition of saliva in between dialysis appointments. However, to study these hypotheses, data are needed on the types of substances that may contribute to the disguesia. Substances for which the concentration is influenced by kidney function (in healthy people) or dialysis (in patients) are the prime candidates for the disguesia under our hypotheses. Thus, this experiment tests whether taste or flavours experienced from sodium, calcium, potassium, creatinine, urea, phosphates, glutamate, and iron may be related to altered taste experienced by patients on dialysis.

Study Overview

Status

Completed

Detailed Description

A. Background:

Individuals on dialysis due to kidney failure have very prescriptive diets. These diets help increase dialysis effectiveness and help patients control blood levels of electrolytes including potassium and phosphate, acid-base balance, blood pressure, and fluid between dialysis treatments. However, patient compliance with these diets is often very low, and one reason for this low compliance is disguesia (abnormal taste sensations) which can make the diets unpalatable. The investigators hypothesize this disguesia, and subsequent lack of adherence to a dialysis friendly diet, is a result of either vascular taste (tasting one's own blood through the basolateral side of taste cells) or altered chemical composition of saliva in between dialysis appointments. However, to study these hypotheses, data are needed on the types of substances that may contribute to the disguesia. Substances for which the concentration is influenced by kidney function (in healthy people) or dialysis (in patients) are the prime candidates for the disguesia under our hypotheses.

B. Objectives:

The investigators will study how dialysis patients perceive sodium, calcium, potassium, creatinine, urea, phosphate, glutamate (umami taste), and iron solutions, and whether alterations in saliva may contribute to altered sensations from these compounds. These solutions will be used to:

  1. Determine whether dialysis patients recognize the flavour of specific stimuli as similar to the disguesias experienced between dialysis treatments.
  2. Determine if the intensity of the flavour from these solutions is more or less intense at the beginning of dialysis compared to the end.
  3. Determine if patients' ratings for the solutions differ from healthy, control individuals.
  4. Determine if saliva of patients contains different concentrations of analytes such as sodium, potassium, creatinine, urea, phosphates, iron, or glutamates from healthy controls.
  5. Determine if concentrations of these analytes in saliva decrease over the course of dialysis treatment.

Study Type

Observational

Enrollment (Actual)

55

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

    • Indiana
      • West Lafayette, Indiana, United States, 47907
        • Purdue University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects will be patients (N=36) undergoing hemodialysis and healthy controls (N=36), for comparison.

Description

HD subjects:

Inclusion

  • Men and women
  • Any race
  • Age 18 years or older
  • Maintenance hemodialysis patients

Exclusion

• Patients with dysphagia who are not able consume the test solutions (clear, thin liquids).

Control subjects:

Inclusion

  • No tongue, lip, or cheek piercings
  • Over 18 years of age
  • Normal taste and smell function
  • No known issues with salivation or dry mouth
  • Willing to comply with study protocol (taste samples and provide saliva)

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Hemodialysis Patients

Inclusion Criteria:

  • Patient's undergoing hemodialysis.
  • Male and female of any race
  • 18 years/ older.

Those with dysphagia were excluded.

In both participant groups, before each tasting protocol commences, sterile cotton dental rolls will be placed in the participant's mouth. This will be used to collect a saliva sample and determine salivary flow.

Tasting Protocol: The hemodialysis patients will taste each solutions twice, both before and after their dialysis session. An sensory questionnaire and an open ended comment box will be given for participants to type in other words to describe the sensations.

In dialysis patients only, blood will be drawn pre and post dialysis for serum ion concentrations.

Healthy Controls

Inclusion Criteria

  • No tongue, lip, or cheek piercings
  • Over 18 years of age
  • Normal taste and smell function
  • No known issues with salivation or dry mouth
  • Willing to comply with study protocol (taste samples and provide saliva)

The above protocol will be mimicked in the healthy control group. The only difference is that instead of a pre/post dialysis tastings, the control population will have a 2-4 hour gap in between tastings in order to follow the approximate time-frame of the dialysis patients. Finally they will not be required to provide blood samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Taste perception
Time Frame: 1 day
Assess effect of dialysis on taste perceptions of solutions via sensory questionnaire. The scale used will be a generalized visual analog scale, which will ask participants about the intensity and hedonic quality of the sensations experienced. The scale ranges from 0 to 100 and are rated by the individuals when tasting the samples.
1 day

Collaborators and Investigators

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

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.

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 (Actual)

February 6, 2017

Primary Completion (Actual)

April 19, 2017

Study Completion (Actual)

April 19, 2017

Study Registration Dates

First Submitted

November 5, 2017

First Submitted That Met QC Criteria

April 4, 2018

First Posted (Actual)

April 11, 2018

Study Record Updates

Last Update Posted (Actual)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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 End Stage Renal Disease

3
Subscribe