Recording Facial Expressions to Assess Taste in Children and Teenagers

Completed

• Conditions: Facial Expression

• Registration Number: NCT02923908
• Lead Sponsor: Arkansas Children's Hospital Research Institute

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.

Detailed Description

Participants will taste three different substances in random order: 1. Prednisone liquid (a commonly used medicine to treat swelling which is approved by the Food and Drug Administration) for use in children; 2. A solution of table sugar in water (simple syrup); and 3. Ora-Plus, which is a solution that can be added to medicines. Ora-Plus is considered safe for use in children's formulas and all of the ingredients of Ora-Plus are on the Food and Drug Administration (FDA) Generally Regarded as Safe (GRAS) list. About 1 ml of each substance will be placed directly onto the tongue. Each substance will be tasted for 5-10 seconds and then, expectorated. Participants and investigators recording responses will be blinded with regard to the identity of test substances.

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.

Study Timeline

• Study First Submitted: 2016-09-30
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-05
• Study Start: 2016-12
• Primary Completion: 2017-06-01
• Study Completion: 2017-06-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-09
• Last Update Posted: 2018-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

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.
• Participant does not pass the baseline medical assessment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evidence that recording of facial expressions can reliably distinguish between liquids that taste bitter, sweet, or have no taste	within one year of study procedure	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.

Trial Locations

Locations (1)

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States