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Recording Facial Expressions to Assess Taste in Children and Teenagers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02923908
Recruitment Status : Completed
First Posted : October 5, 2016
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Facial Expression Other: Noldus Facereader 7 Other: Voice Recording Other: 5-Point Facial Hedonic Scale Other: Follow-Up Questionnaire

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.

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study of Facial Recognition Software to Assess Palatability in Pediatric Patients
Study Start Date : December 2016
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : June 1, 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: 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.
  • Other: Voice Recording
    A voice recording will be made for the duration of the tasting period.
  • Other: 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.
  • Other: Follow-Up Questionnaire
    Participants will be asked a few questions about each test agent after tastings.


Primary Outcome Measures :
  1. Evidence that recording of facial expressions can reliably distinguish between liquids that taste bitter, sweet, or have no taste [ Time Frame: 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.


Other Outcome Measures:
  1. Audio Recording During Study Procedure [ Time Frame: within one year of study procedure ]
    An audio recording will occur during the tasting of each liquid in order to capture the subject's response to the liquid. This recording will be analyzed to determine a subject's liking/disliking of each test agent.


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923908


Locations
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United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Investigators
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Principal Investigator: Gregory L Kearns, PharmD, PhD Arkansas Children's Research Institute

Additional Information:
Publications:
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.

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Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02923908    
Other Study ID Numbers: GK003
20162192 ( Other Identifier: Western Institutional Review Board )
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be made available. However, the overall results of the study will be made available.
Keywords provided by Arkansas Children's Hospital Research Institute:
Palatability
Pediatrics
Facial Recognition
Taste
Facial Expressions
Additional relevant MeSH terms:
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Facies
Disease Attributes
Pathologic Processes