Efficacy of Bitter Blockers on Taste Perception in Children and Adults (BL)
This study is currently recruiting participants.
Verified March 2012 by Monell Chemical Senses Center
Sponsor:
Monell Chemical Senses Center
Collaborator:
Information provided by (Responsible Party):
Julie A. Mennella, Monell Chemical Senses Center
ClinicalTrials.gov Identifier:
NCT01407939
First received: July 19, 2011
Last updated: March 2, 2012
Last verified: March 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 19, 2011 | ||||||||
| Last Updated Date | March 2, 2012 | ||||||||
| Start Date ICMJE | April 2011 | ||||||||
| Estimated Primary Completion Date | April 2016 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Proportion of subjects who rate bitter solutions with added bitter blockers as less bitter than the bitter solution alone. [ Time Frame: 2 hours ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01407939 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Efficacy of Bitter Blockers on Taste Perception in Children and Adults | ||||||||
| Official Title ICMJE | Efficacy of Bitter Taste Blockers on Flavor Acceptance in Pediatric Populations | ||||||||
| 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. |
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| Detailed Description | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Biospecimen | Retention: Samples With DNA Description: Saliva |
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| 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. |
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| Condition ICMJE | Healthy | ||||||||
| Intervention ICMJE | |||||||||
| Study Group/Cohort (s) | Children, Adults
3- to 10-year old children and their parent (adults |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 600 | ||||||||
| Estimated Completion Date | April 2016 | ||||||||
| Estimated Primary Completion Date | April 2016 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 3 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01407939 | ||||||||
| Other Study ID Numbers ICMJE | 809789, 1R01DC011287-01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Julie A. Mennella, Monell Chemical Senses Center | ||||||||
| Study Sponsor ICMJE | Monell Chemical Senses Center | ||||||||
| Collaborators ICMJE | National Institute on Deafness and Other Communication Disorders (NIDCD) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Monell Chemical Senses Center | ||||||||
| Verification Date | March 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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