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

NCT03495271 | Completed DMC

• 1 other identifier: 1611018504
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Keywords

Hemodialysis; Taste; Blood; Saliva

Outcome Measures

Primary Outcomes (1)

• Taste perception

  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

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Purdue University: lead

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (2)

• 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.

  PMID: 23046735 BACKGROUND

• 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.

  PMID: 25653941 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples and saliva samples collected. This is not an intervention; it is observational. Subjects will taste samples, and blood and saliva will be collected. No treatment is assigned.

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Nutrition Science

Study Record Dates

• First Submitted: November 5, 2017
• First Posted: April 11, 2018
• Study Start: February 6, 2017
• Primary Completion: April 19, 2017
• Study Completion: April 19, 2017
• Last Updated: April 18, 2018

Record last verified: 2018-04

Locations

US (1)