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Efficacy of Bitter Blockers on Taste Perception in Children and Adults (BL)

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ClinicalTrials.gov Identifier: NCT01407939
Recruitment Status : Completed
First Posted : August 2, 2011
Last Update Posted : March 16, 2016
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Julie A. Mennella, Monell Chemical Senses Center

Tracking Information
First Submitted Date July 19, 2011
First Posted Date August 2, 2011
Last Update Posted Date March 16, 2016
Study Start Date April 2011
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 1, 2011)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01407939 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 1, 2011)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Efficacy of Bitter Blockers on Taste Perception in Children and Adults
Official Title 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Saliva
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.

Condition Healthy
Intervention Not Provided
Study Groups/Cohorts Children, Adults
3- to 15-year old children and their parent (adults
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 14, 2016)
215
Original Estimated Enrollment
 (submitted: August 1, 2011)
600
Actual Study Completion Date March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01407939
Other Study ID Numbers 809789
1R01DC011287-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Julie A. Mennella, Monell Chemical Senses Center
Study Sponsor Monell Chemical Senses Center
Collaborators National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Julie A. Mennella, PhD Monell Chemical Senses Center
PRS Account Monell Chemical Senses Center
Verification Date March 2016