Efficacy of Bitter Blockers on Taste Perception in Children and Adults (BL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01407939|
Recruitment Status : Completed
First Posted : August 2, 2011
Last Update Posted : March 16, 2016
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||215 participants|
|Official Title:||Efficacy of Bitter Taste Blockers on Flavor Acceptance in Pediatric Populations|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
3- to 15-year old children and their parent (adults
- 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.
- 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.
- 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407939
|United States, Pennsylvania|
|Monell Chemical Senses Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Julie A. Mennella, PhD||Monell Chemical Senses Center|