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

NCT ID: NCT03495271

Last Updated: 2018-04-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-06
• Study Completion Date: 2017-04-19

Brief Summary

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.

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.

Conditions

End Stage Renal Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Purdue University

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Hill Gallant

Assistant Professor of Nutrition Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Purdue University

West Lafayette, Indiana, United States

Countries

United States

References

Lynch KE, Lynch R, Curhan GC, Brunelli SM. Altered taste perception and nutritional status among hemodialysis patients. J Ren Nutr. 2013 Jul;23(4):288-295.e1. doi: 10.1053/j.jrn.2012.08.009. Epub 2012 Oct 6.

Reference Type: BACKGROUND

PMID: 23046735 (View on PubMed)

Seethalakshmi C, Koteeswaran D, Chiranjeevi V. Correlation of Serum and Salivary Biochemical Parameters in end Stage Renal Disease Patients Undergoing Hemodialysis in Pre and Post-Dialysis State. J Clin Diagn Res. 2014 Dec;8(12):CC12-4. doi: 10.7860/JCDR/2014/10404.5306. Epub 2014 Dec 5.

Reference Type: BACKGROUND

PMID: 25653941 (View on PubMed)

Other Identifiers

1611018504

Identifier Type: -

Identifier Source: org_study_id