Recording Facial Expressions to Assess Taste in Children and Teenagers
NCT ID: NCT02923908
Last Updated: 2018-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
12 participants
OBSERVATIONAL
2016-12-31
2017-06-01
Brief Summary
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Detailed Description
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Facial expression will be recorded prior to administration of the taste substances and for approximately 2 minutes thereafter. An audio recording of the participant's voice will also be made during this time. At about 5 and 10 minutes after a given taste substance is administered, participants will be asked to identify a face on a 5-point facial hedonic scale which shows the participant's taste perception. Participants will also be asked to describe the taste sensation experienced as sweet, bitter or neutral (no apparent taste).
Participants will have a 30-minute rest period after administration of each taste substance which will include the administration of water and a neutral food to enable cleansing of the palate. The procedure above will be repeated in the same way for each of the 3 test substances.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Noldus Facereader 7
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
A voice recording will be made for the duration of the tasting period.
5-Point Facial Hedonic Scale
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
Participants will be asked a few questions about each test agent after tastings.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* Participant does not pass the baseline medical assessment.
7 Years
16 Years
ALL
Yes
Sponsors
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Arkansas Children's Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Gregory L Kearns, PharmD, PhD
Role: PRINCIPAL_INVESTIGATOR
Arkansas Children's Research Institute
Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
Countries
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References
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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.
Matsui D. Current issues in pediatric medication adherence. Paediatr Drugs. 2007;9(5):283-8. doi: 10.2165/00148581-200709050-00001.
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.
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.
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.
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.
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.
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.
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.
Loijens, Leanne, et. al. FaceReader: Reference Manual Version 7. Noldus Information Technology. Wageningen, 2016, pp. 55.
Related Links
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FDA Approval of Prednisone Oral Solution 5mg/5mL
Other Identifiers
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20162192
Identifier Type: OTHER
Identifier Source: secondary_id
GK003
Identifier Type: -
Identifier Source: org_study_id
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