Skip to main content
OpenTrials
Completed

NCT Number: NCT01407939

Efficacy of Bitter Blockers on Taste Perception in Children and Adults

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

3 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Monell Chemical Senses Center

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proportion of subjects who rate bitter solutions with added bitter blockers as less bitter than the bitter solution alone.

    Time frame: 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 outcomes

  1. Biometrics and Genotype

    Time frame: 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.

  2. Differences in bitterness ratings obtained via different pediatric taste-assessment methodologies.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Monell Chemical Senses Center

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Efficacy of Bitter Taste Blockers on Flavor Acceptance in Pediatric Populations

Acronym: BL

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Aug 2, 2011
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.