NCT01407939|Completed
Efficacy of Bitter Blockers on Taste Perception in Children and Adults
BL
Efficacy of Bitter Taste Blockers on Flavor Acceptance in Pediatric Populations
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Efficacy of Bitter Taste Blockers on Flavor Acceptance in Pediatric Populations
Sponsor study identifier
Secondary identifiers
observational
215
1 country
1
Study Start
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2016
Actual (reported)Study Completion
March 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
July 19, 2011
Actual (reported)August 2, 2011
Actual (reported)March 2016
Actual (reported)March 2016
Actual (reported)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
Biometrics and Genotype
One year
Differences in bitterness ratings obtained via different pediatric taste-assessment methodologies.
2 hours
3- to 15-year old children and their parent (adults
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.
Monell Chemical Senses Center
Philadelphia, Pennsylvania, 19104, United States
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.
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.
Saliva
Julie A. Mennella, PhD
Monell Chemical Senses Center
215 participants (actual enrollment reported by the registry).
First Submitted
July 19, 2011
First Posted
August 2, 2011
Study Start
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
Effect of Body Composition and Metabolism on Oocyte Gene Expression
Contact the study team to confirm eligibility.
Primary Completion
March 2016
Actual (reported)Study Completion
March 2016
Actual (reported)Last Updated
March 16, 2016
Record last verified: 2016-03
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Source: ClinicalTrials.gov.
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