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

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

Study Description

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.

Condition or disease
Healthy

Study Design

• Study Type: Observational
• Actual Enrollment: 215 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• 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

Groups and Cohorts

Group/Cohort
Children, Adults; 3- to 15-year old children and their parent (adults

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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

Saliva

Eligibility Criteria

• Ages Eligible for Study: 3 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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.

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

Contacts and Locations

Locations

United States, Pennsylvania

Monell Chemical Senses Center

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Monell Chemical Senses Center

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

• Principal Investigator: Julie A. Mennella, PhD; Monell Chemical Senses Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Julie A. Mennella, Member, Monell Chemical Senses Center
• ClinicalTrials.gov Identifier: NCT01407939
• Other Study ID Numbers: 809789; 1R01DC011287-01 ( U.S. NIH Grant/Contract )
• First Posted: August 2, 2011
• Last Update Posted: March 16, 2016
• Last Verified: March 2016

Keywords provided by Julie A. Mennella, Monell Chemical Senses Center:

Bitter Taste; Bitter Blockers; Pediatric Medications; Sensory methodology; Children