NCT01399944|Completed
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Sponsor study identifier
Secondary identifiers
observational
70
1 country
1
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2013
Actual (reported)Study Completion
June 2013
Actual (reported)This single-site, within-subject, experimental study is designed to test the hypothesis that individuals express taste receptors differently and have different sensitivities to bitter taste samples, which results from uneven expression. Subjects will include 100 racially and ethnically diverse, healthy adults. All subjects will provide saliva samples for genetic analysis and undergo taste testing with common psychophysical stimuli. From the pool of 100 subjects, 36 subjects from the common heterozygous group (PAV/AVI) and two from each homozygous group (AVI/AVI, nontaster and PAV/PAV, taster) will be invited to return for two additional sessions. During both sessions the investigators will 1) measure bitterness thresholds for PROP, a common psychophysical stimulus; 2) measure bitterness perception of several vegetables; 3) obtain a saliva sample and 4) collect taste papillae. The investigators will then isolate DNA and RNA from the taste papillae and isolate DNA from saliva to evaluate molecular differences over time and between individuals and how it relates to taste psychophysics. All psychophysical and cellular measurements will be done during both sessions so that the investigators can determine how much variation is observed over a one-week time period in both cellular phenotype and psychophysical phenotype.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
July 20, 2011
Actual (reported)July 22, 2011
Actual (reported)June 2013
Actual (reported)June 2013
Actual (reported)Bitter taste thresholds
Thresholds for propylthiouracil (PROP) will be measured using modified Harris-Kalmus recognition thresholds.
2 days of testing (2 hours each)
Taste intensity and hedonic ratings of vegetables
Subjects will rate the intensity of five basic taste qualities (bitter, salt, sweet, sour, umami) and the liking of PROP, urea, quinine, caffeine, denatonium solutions and pureed vegetables using the general labelled magnitude scale (gLMS)
3 days of testing (1-2 hours each)
TAS2R Genotype
Genotype of several TAS2Rs will be determined from DNA extracted from a saliva sample.
1 day of testing (1-1.5 hours)
mRNA expression levels
Expression of taste and related genes will be determined from mRNA extracted from human taste tissue obtained via tongue biopsy.
2 days of testing (2 hours each)
Dietary habits
2 days (2 hours each)
biometrics
1 day (1-1.5 hours)
Adults of all races and both genders (N=100) will be involved in the proposed research. Typically, our population of subjects is approximately 45% African American, 45% Caucasian, 6% Hispanic, and 4% Asian. This increased representation of under-represented minorities in our subject populations is reflective of the greater Philadelphia region and has been achieved, in part, through our outreach efforts advertising in local newspapers throughout the city.
Contact the study team to confirm eligibility.
Monell Chemical Senses Center
Philadelphia, Pennsylvania, 19104, United States
Lipchock SV, Mennella JA, Spielman AI, Reed DR. Human bitter perception correlates with bitter receptor messenger RNA expression in taste cells. Am J Clin Nutr. 2013 Oct;98(4):1136-43. doi: 10.3945/ajcn.113.066688. Epub 2013 Sep 11.
Saliva and taste tissue will be collected from individuals enrolled in the study.
Julie A. Mennella, PhD
Monell Chemical Senses Center
70 participants (actual enrollment reported by the registry).
First Submitted
July 20, 2011
First Posted
July 22, 2011
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Sensory Evaluation of the Taste of Pediatric Medicines
Primary Completion
June 2013
Actual (reported)Study Completion
June 2013
Actual (reported)Last Updated
December 18, 2017
Record last verified: 2017-12
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Source: ClinicalTrials.gov.
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