Efficacy of Bitter Blockers on Taste Perception in Children and Adults

NCT01407939 | Completed

• 2 other identifiers: 8097891R01DC011287-01
• Study Type: observational
• Target: 215
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects who rate bitter solutions with added bitter blockers as less bitter than the bitter solution alone.

  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.

  2 hours

Secondary Outcomes (2)

• Biometrics and Genotype

  One year

• Differences in bitterness ratings obtained via different pediatric taste-assessment methodologies.

  2 hours

Study Arms (1)

Children, Adults

3- to 15-year old children and their parent (adults

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Children who are on any medications that may alter taste sensitivity
• Mothers who are pregnant

Sponsors & Collaborators

• Monell Chemical Senses Center: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Monell Chemical Senses Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• 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.

  PMID: 26391354 DERIVED

• 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.

  PMID: 25050705 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

Study Officials

• Julie A. Mennella, PhD

  Monell Chemical Senses Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Member

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: August 2, 2011
• Study Start: April 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

US (1)