Efficacy of Bitter Blockers on Taste Perception in Children and Adults

Completed

• Conditions: Healthy

• Registration Number: NCT01407939
• Lead Sponsor: Monell Chemical Senses Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-07-19
• Study First Submitted QC: 2011-08-01
• Study First Posted: 2011-08-02
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-14
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who rate bitter solutions with added bitter blockers as less bitter than the bitter solution alone.	2 hours	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.

Secondary Outcome Measures

Name	Time	Method
Biometrics and Genotype	One year	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.	2 hours	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.

Trial Locations

Locations (1)

Monell Chemical Senses Center; 🇺🇸 Philadelphia, Pennsylvania, United States