Efficacy of Bitter Blockers on Taste Perception in Children and Adults

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Bitter Taste Blockers on Flavor Acceptance in Pediatric Populations

Conditions
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Healthy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, term children of either sex and all races/ethnicities will be eligible for this study. Children must be between 3 and 10 years of age. Exclusion Criteria: Children who are on any medications that may alter taste sensitivity Mothers who are pregnant

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children, Adults<br>3- to 15-year old children and their parent (adults | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who rate bitter solutions with added bitter blockers as less bitter than the bitter solution alone. | 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. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biometrics and Genotype | 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. | One year | 
| Differences in bitterness ratings obtained via different pediatric taste-assessment methodologies. | 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. | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bitter Taste, Bitter Blockers, Pediatric Medications, Sensory methodology, Children