HealthyMEDTASTENCT03627351
Sensory Evaluation of the Taste of Pediatric Medicines
An observational study of Healthy, run by Monell Chemical Senses Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy men and women between the ages of 18 and 55 years
Who may be able to join
- Men and women who are between the ages of 18 and 55 years
Who cannot join
- 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)
Show all 24Show fewer
- 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)
- Ranolazine (Ranexa; anti-anginal)
- Simvastatin (Zocor; statin)
- Terfenadine (Seldane; antihistamine)
- Tinidazole (Tindamax; anti-parasitic)
- Trazodone (Desyrel; antidepressant/sedative)
- Triazolam (Halcion; sedative)
- Warfarin (Coumadin; blood thinner)
- Potential subjects will be excluded if they have had current (within the last 24 hours) use of sildenafil (Viagra), tadalafil (Cialis), and verdenafil (Levitra) are also exclusion criteria. These drugs can be used as needed for erectile dysfunction. They are also used as a daily treatment for pulmonary arterial hypertension. With CYP450 3A4 blockade and current use, hypotension, syncope, and prolonged erection are possible.
- Potential subjects will be excluded if they have known allergies or hypersensitivity reactions to lopinavir, ritonavir, clindamycin, prednisone, dexamethasone, ibuprofen, 6-mercaptopurine, propylthiouracil, or any of the excipients in the liquid formulations to be tested.
Trial locations and contacts
1 site in 1 country.
United States1 site
Monell Chemical Senses Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Taste of Medicines for Children: Genetic Variation and Medical Adherence (Aim 1)
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).
Read the detailed description
This is a single-site, cross-sectional, repeated measures study of healthy adult panelists which will investigate individual differences in the taste of a diverse set of commonly used pediatric liquid medications (e.g., clindamycin, prednisone, dexamethasone, mercaptopurine, ibuprofen, lopinavir/ritonavir, propylthiouracil) and excipients (e.g., sucrose, citric acid, bitter agents, salt, menthol and other odors) in tandem with genetic analysis. Because the medication given to pediatric patients is the whole liquid formulation (API + excipients), the investigators' approach will be to have panelists taste (without swallowing) what patients taste. Using validated psychophysical tools such as the general labelled magnitude scale (gLMS), the hedonic gLMS, and the hedonic 5-face scale, adults panelists will rate the intensity of the basic tastes, overall intensity, irritation, or palatability (hedonics) of a variety of pediatric drugs (with and without noseclips), along with generally recognized as safe (GRAS) taste and odor stimuli commonly used in basic research and/or as excipients in many liquid formulations These data will establish whether the palatability and flavor of each medicine varies among adult panelists. From these data, the investigators will determine a) whether the dislike of one medicine by a panelist predicts their dislike of another medicine in the same class or medicines with the same excipients; b) whether variation in the flavor and palatability ratings of each medicine relates to variation in genetic polymorphisms, as determined from the GWAS; and c) whether the panelists' palatability ratings of each medicine, as assessed by the simpler hedonic 5-face scale, is significantly related to hedonic gLMS ratings.
- Conditions
- Healthy
- Keywords
- Taste, Odor, Sensory Panel, Flavor, Genes, Pediatric Medicines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Women and Men | Group of healthy women and men |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 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]
Measured: 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
Measured: After study completion, 2021-2022
Secondary outcomes (1)
Hedonic ratings (using 5 face scale) of the flavor of pediatric medicines
Ratings of the liking of the flavor of each medicine, as assessed by the simpler, hedonic 5-face scale; each medicine is rated individually; range: 1 (minimum, greatest dislike score) to 5 (maximum; greatest liking score). Each panelist's hedonic 5-face scale rating will be correlated with the more sophisticated hedonic gLMS rating for each medicine to lay the foundation for future research in pediatric populations
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start1 Sep 2018
- Primary completion16 Jul 2021
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monell Chemical Senses Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Children's Hospital of Philadelphia
- Responsible party
- Sponsor
- Investigators
- Julie A. Mennella, PhD, Principal investigator, Monell Chemical Senses CenterElizabeth Lowenthal, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627351
- Sponsor's protocol ID
- T24653
- Other IDs
- R01DC011287
- Acronym
- MEDTASTE
- Status last verified
- Mar 2024
- First submitted
- 9 Jul 2018
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: dbGAP
Publications
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.
PubMed 28923290Mennella 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.
PubMed 23886820Kalva 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.
PubMed 24422940Snyder DJ, Prescott J, Bartoshuk LM. Modern psychophysics and the assessment of human oral sensation. Adv Otorhinolaryngol. 2006;63:221-241. doi: 10.1159/000093762.
PubMed 16733341Bobowski 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.
PubMed 28497993Bobowski 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.
PubMed 27966661Kan 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.
PubMed 40594245
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taste of Medicines for Children: Genetic Variation and Medical Adherence (Aim 1)
- ClinicalTrials.gov ID
- NCT03627351
- Acronym / sponsor ID
- MEDTASTE / T24653
- Conditions
- Healthy
- Keywords
- Taste, Odor, Sensory Panel, Flavor, Genes, Pediatric Medicines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Monell Chemical Senses CenterUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Children's Hospital of Philadelphia
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 16 Jul 2021 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a single-site, cross-sectional, repeated measures study of healthy adult panelists which will investigate individual differences in the taste of a diverse set of commonly used pediatric liquid medications (e.g., clindamycin, prednisone, dexamethasone, mercaptopurine, ibuprofen, lopinavir/ritonavir, propylthiouracil) and excipients (e.g., sucrose, citric acid, bitter agents, salt, menthol and other odors) in tandem with genetic analysis. Because the medication given to pediatric patients is the whole liquid formulation (API + excipients), the investigators' approach will be to have panelists taste (without swallowing) what patients taste. Using validated psychophysical tools such as the general labelled magnitude scale (gLMS), the hedonic gLMS, and the hedonic 5-face scale, adults panelists will rate the intensity of the basic tastes, overall intensity, irritation, or palatability (hedonics) of a variety of pediatric drugs (with and without noseclips), along with generally recognized as safe (GRAS) taste and odor stimuli commonly used in basic research and/or as excipients in many liquid formulations These data will establish whether the palatability and flavor of each medicine varies among adult panelists. From these data, the investigators will determine a) whether the dislike of one medicine by a panelist predicts their dislike of another medicine in the same class or medicines with the same excipients; b) whether variation in the flavor and palatability ratings of each medicine relates to variation in genetic polymorphisms, as determined from the GWAS; and c) whether the panelists' palatability ratings of each medicine, as assessed by the simpler hedonic 5-face scale, is significantly related to hedonic gLMS ratings.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Women and Men | – | –Group of healthy women and men |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy men and women between the ages of 18 and 55 years
Key inclusion criteria (1 listed)
- Men and women who are between the ages of 18 and 55 years
Key exclusion criteria (24 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Flavor ratings (using general labelled magnitude scale, gLMS) of pediatric medicines and excipients
Time frame: Through study completion, an average of 3 years
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]
Palatability ratings (using hedonic general labelled magnitude scale, hedonic gLMS) of the flavor of pediatric medicines and excipients
Time frame: Through study completion, an average of 3 years
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]
Detect genetic associations (GWAS) with flavor and palatability ratings of pediatric medicines
Time frame: After study completion, 2021-2022
To detect genetic associations with taste and palatability ratings phenotypes of each medicine
1 secondary outcome
Hedonic ratings (using 5 face scale) of the flavor of pediatric medicines
Time frame: Through study completion, an average of 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Background: PubMed 28923290Mennella 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.
- Background: PubMed 23886820Mennella 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.
- Background: PubMed 24422940Kalva 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.
- Background: PubMed 16733341Snyder DJ, Prescott J, Bartoshuk LM. Modern psychophysics and the assessment of human oral sensation. Adv Otorhinolaryngol. 2006;63:221-241. doi: 10.1159/000093762.
- Background: PubMed 28497993Bobowski 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.
- Background: PubMed 27966661Bobowski 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.
- Derived from this study: PubMed 40594245Kan 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.
- Individual participant dataSharing planned: Yes. dbGAP
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie A. Mennella, PhD principal investigator
Monell Chemical Senses Center
Elizabeth Lowenthal, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Monell Chemical Senses Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flavor ratings (using general labelled magnitude scale, gLMS) of pediatric medicines and excipients (time frame: Through study completion, an average of 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03627351, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.