- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03495271
Pilot Study of Taste Sensations in Patients With End-stage Renal Disease on Hemodialysis
Study Overview
Status
Conditions
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:
- Determine whether dialysis patients recognize the flavour of specific stimuli as similar to the disguesias experienced between dialysis treatments.
- Determine if the intensity of the flavour from these solutions is more or less intense at the beginning of dialysis compared to the end.
- Determine if patients' ratings for the solutions differ from healthy, control individuals.
- Determine if saliva of patients contains different concentrations of analytes such as sodium, potassium, creatinine, urea, phosphates, iron, or glutamates from healthy controls.
- Determine if concentrations of these analytes in saliva decrease over the course of dialysis treatment.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Indiana
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West Lafayette, Indiana, United States, 47907
- Purdue University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Hemodialysis Patients
Inclusion Criteria:
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
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.
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1 day
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1611018504
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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