Efficacy of Bitter Blockers on Taste Perception in Children and Adults (BL)
This study is currently recruiting participants.
Verified October 2013 by Monell Chemical Senses Center
Information provided by (Responsible Party):
Julie A. Mennella, Monell Chemical Senses Center
First received: July 19, 2011
Last updated: October 23, 2013
Last verified: October 2013
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.
||Observational Model: Cohort
Time Perspective: Cross-Sectional
||Efficacy of Bitter Taste Blockers on Flavor Acceptance in Pediatric Populations
Primary Outcome Measures:
Biospecimen Retention: Samples With DNA
Secondary Outcome Measures:
- Biometrics and Genotype [ Time Frame: One year ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2016 (Final data collection date for primary outcome measure)
3- to 10-year old children and their parent (adults
|Ages Eligible for Study:
||3 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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.
- Children who are on any medications that may alter taste sensitivity
- Mothers who are pregnant
Please refer to this study by its ClinicalTrials.gov identifier: NCT01407939
|Monell Chemical Senses Center
|Philadelphia, Pennsylvania, United States, 19104 |
|Contact: Julie A. Mennella, PhD 267-519-4880 firstname.lastname@example.org |
Monell Chemical Senses Center
||Julie A. Mennella, PhD
||Monell Chemical Senses Center
No publications provided
||Julie A. Mennella, Member, Monell Chemical Senses Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 19, 2011
||October 23, 2013
||United States: Institutional Review Board
Keywords provided by Monell Chemical Senses Center:
ClinicalTrials.gov processed this record on December 05, 2013