BL: Efficacy of Bitter Blockers on Taste Perception in Children and Adults

Sponsor
Monell Chemical Senses Center (Other)
Overall Status
Completed
CT.gov ID
NCT01407939
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)
215
1
59
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    215 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Efficacy of Bitter Taste Blockers on Flavor Acceptance in Pediatric Populations
    Study Start Date :
    Apr 1, 2011
    Actual Primary Completion Date :
    Mar 1, 2016
    Actual Study Completion Date :
    Mar 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Children, Adults

    3- to 15-year old children and their parent (adults

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Monell Chemical Senses Center Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • Monell Chemical Senses Center
    • National Institute on Deafness and Other Communication Disorders (NIDCD)

    Investigators

    • Principal Investigator: Julie A. Mennella, PhD, Monell Chemical Senses Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Julie A. Mennella, Member, Monell Chemical Senses Center
    ClinicalTrials.gov Identifier:
    NCT01407939
    Other Study ID Numbers:
    • 809789
    • 1R01DC011287-01
    First Posted:
    Aug 2, 2011
    Last Update Posted:
    Mar 16, 2016
    Last Verified:
    Mar 1, 2016
    Keywords provided by Julie A. Mennella, Member, Monell Chemical Senses Center

    Study Results

    No Results Posted as of Mar 16, 2016