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Genetic Variability in Taste Perception

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ClinicalTrials.gov Identifier: NCT01841710
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : March 16, 2016
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
University of Pennsylvania
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Julie A. Mennella, Monell Chemical Senses Center

Tracking Information
First Submitted Date April 24, 2013
First Posted Date April 26, 2013
Last Update Posted Date March 16, 2016
Study Start Date December 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 25, 2013)
Psychophysical data for taste solutions [ Time Frame: 1-2 hours ]
Primary outcome variables are intensity ratings of pediatric medications as well as a variety of generally recognized as safe bitter and non-bitter compounds.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 25, 2013)
Maternal practices and perceptions of medication use [ Time Frame: 1-2 hours ]
Secondary outcome variables include questions related to maternal practices and perceptions of medication use and compliance of their children.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Genetic Variability in Taste Perception
Official Title Genetic Variability in Taste Perception
Brief Summary This proposal describes a pilot study aimed at determining whether genetic variations in taste receptors determine differential taste tolerability of pediatric medications.
Detailed Description This is a cross-sectional call-back study of taste perception and the relationship between taste perception and taste receptor genotype.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Saliva
Sampling Method Non-Probability Sample
Study Population One hundred women who were previously enrolled in the study entitled "Efficacy of Bitter Blockers on Taste Acceptance in Pediatric Populations," Protocol #809789; will be recruited for the current study
Condition Healthy
Intervention Not Provided
Study Groups/Cohorts Women
Publications * Mennella JA, Mathew PS, Lowenthal ED. Use of Adult Sensory Panel to Study Individual Differences in the Palatability of a Pediatric HIV Treatment Drug. Clin Ther. 2017 Oct;39(10):2038-2048. doi: 10.1016/j.clinthera.2017.08.012. Epub 2017 Sep 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 14, 2016)
90
Original Estimated Enrollment
 (submitted: April 25, 2013)
100
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult females who were previously enrolled in Efficacy of Bitter Blockers on Taste Acceptance in Pediatric Populations Study (Protocol #809789)

Exclusion Criteria:

  • Women who are pregnant
  • Women on drugs with potential serious adverse effects that are mediated through cytochrome P450.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01841710
Other Study ID Numbers 816980
R01DC011287 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Julie A. Mennella, Monell Chemical Senses Center
Study Sponsor Monell Chemical Senses Center
Collaborators
  • Children's Hospital of Philadelphia
  • University of Pennsylvania
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Julie A. Mennella, PhD Monell Chemical Senses Center
Principal Investigator: Elizabeth Lowenthal, MD MSCE University of Pennsylvania
PRS Account Monell Chemical Senses Center
Verification Date March 2016