Efficacy of Bitter Blockers on Taste Perception in Children and Adults (BL)
This proposal describes 2 basic research studies that will be conducted sequentially. Study 1 will test the efficacy of both classic and newly developed "generally recognized as a safe" (GRAS) bitter blockers on the perceived bitterness and acceptance of different classes of bitter-tasting compounds by children and compare their responses to adults. Because variations among and between children and adults in terms of sensitivity to different bitter compounds are due in part to genetically determined receptor variation, the investigators will consider genotype when assessing how well bitter blockers perform. In Study 2, the investigators aim to evaluate different methods (forced-choice procedures, hedonic face scales) used for testing children to determine their reliability and reproducibility.
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Efficacy of Bitter Taste Blockers on Flavor Acceptance in Pediatric Populations|
- Proportion of subjects who rate bitter solutions with added bitter blockers as less bitter than the bitter solution alone. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]Primary outcome variables are the proportion of subjects by age group (children and adults) judging a variety of GRAS bitter compounds with a bitter blocker as less bitter or more pleasant than the bitter compound alone (the efficacy of the bitter blocker). At least 5 bitter compounds and 5 GRAS bitter blockers will be used. We will determine how these measures are affected by the age and genotype of the subjects.
- Biometrics and Genotype [ Time Frame: One year ] [ Designated as safety issue: No ]For both Studies 1 and 2, the secondary outcome variables include age, genotype of various taste receptor genes (e.g., TAS2R38, TAS2R20, TAS2R31), body weight and height.
- Differences in bitterness ratings obtained via different pediatric taste-assessment methodologies. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]We will determine whether the bitter-blocker pairings assessed as most effective by the children using the forced-comparison procedure (bitter alone vs bitter plus blocker) yield statistically different ratings when children use a 3-point, 5-point, or 7-point scale (with happy and sad faces to denote the degree of liking and disliking) after children, of varying ages, taste each of these solutions.
Biospecimen Retention: Samples With DNA
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
3- to 15-year old children and their parent (adults
Please refer to this study by its ClinicalTrials.gov identifier: NCT01407939
|Contact: Julie A. Mennella, PhDfirstname.lastname@example.org|
|Contact: Kristi Roberts, BAemail@example.com|
|United States, Pennsylvania|
|Monell Chemical Senses Center||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Julie A. Mennella, PhD 267-519-4880 firstname.lastname@example.org|
|Principal Investigator:||Julie A. Mennella, PhD||Monell Chemical Senses Center|