Recording Facial Expressions to Assess Taste in Children and Teenagers

NCT02923908 | Completed

• 2 other identifiers: GK00320162192
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to see if, after tasting specific things, whether a child's facial pattern and voice pattern can determine the difference in something that has a sweet taste, no taste, and a bitter taste. The investigators will do this by comparing video recordings of a child's facial expression and voice to the child's response to follow-up questions after tasting three (3) different substances.

Conditions

Facial Expression

Keywords

Palatability; Pediatrics; Facial Recognition; Taste; Facial Expressions

Outcome Measures

Primary Outcomes (1)

• Evidence that recording of facial expressions can reliably distinguish between liquids that taste bitter, sweet, or have no taste

  The investigators propose that Noldus Facereader 7 can adequately discriminate between bitter, sweet, and neutral tastes in children and adolescents. Data collected through these recordings will be compared to ratings of liking/disliking of liquids using a 5-point facial hedonic scale and compared to a questionnaire after each tasting.

  within one year of study procedure

Other Outcomes (1)

• Audio Recording During Study Procedure

  within one year of study procedure

Interventions

Noldus Facereader 7 OTHER

A video recording of a subject's facial expressions while tasting a sweet, bitter, and neutral flavored liquid will be analyzed using Noldus Facereader 7 software.

Voice Recording OTHER

A voice recording will be made for the duration of the tasting period.

5-Point Facial Hedonic Scale OTHER

A 5-point facial hedonic scale will be given to the participant to complete prior to the administration of any test substances and about 5, 10, and 30 minutes after the administration of each test substance.

Follow-Up Questionnaire OTHER

Participants will be asked a few questions about each test agent after tastings.

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be recruited via IRB approved advertisements and from the ACRI database for which subjects have given prior permission to be contacted for research studies. A convenience sample will be comprised of 10 children and/or adolescents ranging in age from 7 to 16 years of age. A total of 13 subjects may be enrolled in the event that a subject is unable to meet criteria and/or needs to withdraw. If the study attains 10 evaluable subjects, then additional participants will not be enrolled.

You may qualify if:

• Participants will be eligible if all of the following criteria is met:
• Verbal assent and parental consent provided.
• Males and females between 7 and ≤16 years of age (n= 3-5 in group 7 to 11 years and n= 4-5 in group 12 to ≤16 years. An additional 3 participants may be recruited if a recording does not produce viable data.)
• Both parent and participant speak English proficiently

You may not qualify if:

• Participants will not be eligible if any of the following criteria is met:
• Unwillingness to participate.
• Participants of Asian ethnicity (N.B. The current FaceReader software cannot correctly identify facial expressions in these children and as a result cannot produce an analysis suitable to this study.14)
• Any medical condition or recent event that would cause a study participant to be unable to taste or swallow study agents.
• Any medical condition, previous surgery, or recent event affecting the tongue or palate that would cause taste alteration or aversion (i.e. ulcerations or infection of the tongue, soft or hard palate).
• Any medical condition or recent event that would preclude a study participant from having an intact sense of smell (i.e. anosmia, history of severe sinus infections, recent upper respiratory infection with congestion).
• Had a dentist visit within 14 days prior to enrollment or the time between enrollment and receipt of study articles.
• Any history of allergy, hypersensitivity, or intolerance to prednisone, sugar, food dyes, or any of the constituents of Ora-Plus.
• Any prior history of cardiac or gastrointestinal problems with the exception of self-limited conditions common to pediatric patients.
• Have ingested any medication or food substance 60 minutes prior to administration of the test articles.
• If the participant is the child or a first-degree relative to any of the investigators.
• Any profound sensory deficit (i.e. vision or hearing) that may interfere with the ability to comply with study related demands.
• Neurocognitive Disorders that could limit interpretation of results and their generalizability.
• History of a chronic illness.
• Use of mouthwash within 24 hours of study visit.

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Related Publications (10)

• Walsh J, Cram A, Woertz K, Breitkreutz J, Winzenburg G, Turner R, Tuleu C; European Formulation Initiative. Playing hide and seek with poorly tasting paediatric medicines: do not forget the excipients. Adv Drug Deliv Rev. 2014 Jun;73:14-33. doi: 10.1016/j.addr.2014.02.012. Epub 2014 Mar 12.

  PMID: 24614069 BACKGROUND

• Matsui D. Current issues in pediatric medication adherence. Paediatr Drugs. 2007;9(5):283-8. doi: 10.2165/00148581-200709050-00001.

  PMID: 17927300 BACKGROUND

• Wollner A, Lecuyer A, De La Rocque F, Sedletzki G, Derkx V, Boucherat M, Elbez A, Gelbert-Baudino N, Levy C, Corrard F, Cohen R. [Acceptability, compliance and schedule of administration of oral antibiotics in outpatient children]. Arch Pediatr. 2011 May;18(5):611-6. doi: 10.1016/j.arcped.2011.02.010. Epub 2011 Mar 21. French.

  PMID: 21420838 BACKGROUND

• Winnick S, Lucas DO, Hartman AL, Toll D. How do you improve compliance? Pediatrics. 2005 Jun;115(6):e718-24. doi: 10.1542/peds.2004-1133.

  PMID: 15930200 BACKGROUND

• Sjovall J, Fogh A, Huitfeldt B, Karlsson G, Nylen O. Methods for evaluating the taste of paediatric formulations in children: a comparison between the facial hedonic method and the patients' own spontaneous verbal judgement. Eur J Pediatr. 1984 Feb;141(4):243-7. doi: 10.1007/BF00572770.

  PMID: 6734676 BACKGROUND

• Tolia V, Johnston G, Stolle J, Lee C. Flavor and taste of lansoprazole strawberry-flavored delayed-release oral suspension preferred over ranitidine peppermint-flavored oral syrup: in children aged between 5-11 years. Paediatr Drugs. 2004;6(2):127-31. doi: 10.2165/00148581-200406020-00006.

  PMID: 15035653 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

• 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 BACKGROUND

• Danner, Lukas, Liudmila Sidorkina, Max Joechl, Klaus Duerrschmid. Make a face! Implicit and explicit measurement of facial expressions elicited by orange juices using face reading technology. Elsevier: Food Quality and Preference. 2013; 32:167-172.

  BACKGROUND

• Loijens, Leanne, et. al. FaceReader: Reference Manual Version 7. Noldus Information Technology. Wageningen, 2016, pp. 55.

  BACKGROUND

Related Links

• FDA Approval of Prednisone Oral Solution 5mg/5mL

Biospecimen

Retention: SAMPLES WITH DNA

Using a sample of saliva or swabbed buccal mucosa, a given DNA sample will be analyzed for allelic variants of a gene (TAS2R38), which controls the expression of the bitter taste receptor in each subject. This analysis will be exploratory in nature and its value would be to investigate any potential genotype-phenotype discordance in a given participant in response to the bitter (Prednisone) test substance. The DNA samples will only be used to assess genomic interactions in taste response.

MeSH Terms

Conditions

Facial Expression

Condition Hierarchy (Ancestors)

Nonverbal Communication; Communication; Behavior

Study Officials

• Gregory L Kearns, PharmD, PhD

  Arkansas Children's Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: October 5, 2016
• Study Start: December 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: April 10, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)