Clinical trial NCT01407939: Efficacy of Bitter Blockers on Taste Perception in Children and Adults
Official title: Efficacy of Bitter Taste Blockers on Flavor Acceptance in Pediatric Populations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Bitter Taste
Bitter Blockers
Pediatric Medications
Sensory methodology
Children
Lead sponsor: Monell Chemical Senses Center
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2011-08-02
Enrollment: 215
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Total number of subjects to be enrolled into the study: 300 mothers and 300 children (ages 3-10) =600 total subjects.

Mothers will be recruited from the community of greater Philadelphia through newspaper and online ads and initial interviews are conducted over the telephone.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects who rate bitter solutions with added bitter blockers as less bitter than the bitter solution alone.
timeFrame: 2 hours
Secondary outcomes:
measure: Biometrics and Genotype
timeFrame: One year
measure: Differences in bitterness ratings obtained via different pediatric taste-assessment methodologies.
timeFrame: 2 hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Monell Chemical Senses Center
state: Pennsylvania
Study officials:
affiliation: Monell Chemical Senses Center
name: Julie A. Mennella, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mennella JA, Roberts KM, Mathew PS, Reed DR. Children's perceptions about medicines: individual differences and taste. BMC Pediatr. 2015 Sep 21;15:130. doi: 10.1186/s12887-015-0447-z.
citation: Mennella JA, Reed DR, Roberts KM, Mathew PS, Mansfield CJ. Age-related differences in bitter taste and efficacy of bitter blockers. PLoS One. 2014 Jul 22;9(7):e103107. doi: 10.1371/journal.pone.0103107. eCollection 2014.