Sensory Evaluation of the Taste of Pediatric Medicines

NCT03627351 | Completed

• 2 other identifiers: T24653R01DC011287
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct a systematic study of the sensory perception of a diverse set of commonly used pediatric liquid medications and excipients in tandem with an equally complete genetic analysis of the adult sensory panelists to investigate the relationship between genetic variation and individual differences in the perceived flavor (taste, smell, irritation) of pediatric medicines. The flavor of each medicine and excipient will be measured individually using both cognitively demanding methods unsuitable for young children and simpler measures validated for use by children. Salivary DNA samples will be collected to carry out genome wide association study (GWAS).

Conditions

Healthy

Keywords

Taste; Odor; Sensory Panel; Flavor; Genes; Pediatric Medicines

Outcome Measures

Primary Outcomes (3)

• Flavor ratings (using general labelled magnitude scale, gLMS) of pediatric medicines and excipients

  Flavor ratings of each pediatric medicine and excipient as assessed by the general labelled magnitude scale \[gLMS\]; each medicine and each excipient is rated individually; range 0 \[minimum, no flavor\] to 100 \[maximum; strongest flavor rating\]

  Through study completion, an average of 3 years

• Palatability ratings (using hedonic general labelled magnitude scale, hedonic gLMS) of the flavor of pediatric medicines and excipients

  Ratings of the palatabillity of the flavor of each medicine and excipient, as assessed by the hedonic general labelled magnitude scale; each medicine and each excipient is rated individually, range: -100 \[minimum palatability rating\] to 0 \[neither like nor dislike\] to 100 \[maximum /strongest imaginable palatability ratings\]

  Through study completion, an average of 3 years

• Detect genetic associations (GWAS) with flavor and palatability ratings of pediatric medicines

  To detect genetic associations with taste and palatability ratings phenotypes of each medicine

  After study completion, 2021-2022

Secondary Outcomes (1)

• Hedonic ratings (using 5 face scale) of the flavor of pediatric medicines

  Through study completion, an average of 3 years

Study Arms (1)

Healthy Women and Men

Group of healthy women and men

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy men and women between the ages of 18 and 55 years

You may qualify if:

• \- Men and women who are between the ages of 18 and 55 years

You may not qualify if:

• For all female participants, a urine pregnancy test will be done on each testing day. Only those with a negative pregnancy test will be allowed to participate in taste testing.
• Smokers will be excluded since it alters flavor perception.
• Potential subjects will be excluded if they are on drugs with potential serious adverse effects that are mediated through CYP450 3A4 since ritonavir is a potent inhibitor of CYP450 3A4 and could lead to elevated levels of the prohibited drugs if swallowed. The prohibited drugs include the following:
• Alfuzosin (Uroxatral; alpha-1-adrenoreceptor antagonist)
• Astemizole (Hismanal; antihistamine)
• Bepridil (Vascor; calcium channel blocker)
• Cerivastatin (Baycol; statin)
• Cisapride (Propulsid; GI motility agent)
• Dronedarone (multaq; anti-arrhythmic)
• Ergotamine (Cafergot, Ergot derivatives)
• Flecainide (Tabocor; anti-arrhythmic)
• Lovastatin (Altoprev; HMG-CoA Reductase Inhibitor)
• Lurasidone (Latuda; antipsychotic)
• Midazolam (Versed; sedative/hypnotic)
• Pimozide (Orap; antipsychotic)

Sponsors & Collaborators

• Monell Chemical Senses Center: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator
• Children's Hospital of Philadelphia: collaborator

Study Sites (1)

Monell Chemical Senses Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (7)

• Mennella JA, Mathew PS, Lowenthal ED. Use of Adult Sensory Panel to Study Individual Differences in the Palatability of a Pediatric HIV Treatment Drug. Clin Ther. 2017 Oct;39(10):2038-2048. doi: 10.1016/j.clinthera.2017.08.012. Epub 2017 Sep 18.

  PMID: 28923290 BACKGROUND

• Mennella JA, Spector AC, Reed DR, Coldwell SE. The bad taste of medicines: overview of basic research on bitter taste. Clin Ther. 2013 Aug;35(8):1225-46. doi: 10.1016/j.clinthera.2013.06.007. Epub 2013 Jul 22.

  PMID: 23886820 BACKGROUND

• Kalva JJ, Sims CA, Puentes LA, Snyder DJ, Bartoshuk LM. Comparison of the hedonic general Labeled Magnitude Scale with the hedonic 9-point scale. J Food Sci. 2014 Feb;79(2):S238-45. doi: 10.1111/1750-3841.12342. Epub 2014 Jan 14.

  PMID: 24422940 BACKGROUND

• Snyder DJ, Prescott J, Bartoshuk LM. Modern psychophysics and the assessment of human oral sensation. Adv Otorhinolaryngol. 2006;63:221-241. doi: 10.1159/000093762.

  PMID: 16733341 BACKGROUND

• Bobowski N, Mennella JA. Personal Variation in Preference for Sweetness: Effects of Age and Obesity. Child Obes. 2017 Oct;13(5):369-376. doi: 10.1089/chi.2017.0023. Epub 2017 May 12.

  PMID: 28497993 BACKGROUND

• Bobowski N, Reed DR, Mennella JA. Variation in the TAS2R31 bitter taste receptor gene relates to liking for the nonnutritive sweetener Acesulfame-K among children and adults. Sci Rep. 2016 Dec 14;6:39135. doi: 10.1038/srep39135.

  PMID: 27966661 BACKGROUND

• Kan M, Saraiva LR, Hwang LD, Lowenthal ED, Himes BE, Mennella JA. Genome-wide association study of the taste and hedonic ratings of the low-calorie sweetener acesulfame potassium. Sci Rep. 2025 Jul 1;15(1):22121. doi: 10.1038/s41598-025-05739-x.

  PMID: 40594245 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Identification of genetic polymorphisms in DNA from saliva samples collected at baseline that are associated with variation in flavor and palatability ratings of pediatric medicines through genome wide association study of adult panelists

Study Officials

• Julie A. Mennella, PhD

  Monell Chemical Senses Center

  PRINCIPAL INVESTIGATOR

• Elizabeth Lowenthal, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: August 13, 2018
• Study Start: September 1, 2018
• Primary Completion: July 16, 2021
• Study Completion: March 1, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 2023 and for 1 year
• Access Criteria: To be developed

Locations

US (1)