HealthyNCT01841710

Genetic Variability in Taste Perception

An observational study of Healthy, run by Monell Chemical Senses Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This proposal describes a pilot study aimed at determining whether genetic variations in taste receptors determine differential taste tolerability of pediatric medications. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
How many people: 90 participants
Where: 1 siteUnited States
Study dates: Dec 2012to Dec 2015
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 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Study population: One hundred women who were previously enrolled in the study entitled "Efficacy of Bitter Blockers on Taste Acceptance in Pediatric Populations," Protocol #809789; will be recruited for the current study

Who may be able to join

Adult females who were previously enrolled in Efficacy of Bitter Blockers on Taste Acceptance in Pediatric Populations Study (Protocol #809789)

Who cannot join

Women who are pregnant
Women on drugs with potential serious adverse effects that are mediated through cytochrome P450.

Trial locations and contacts

1 site in 1 country.

United States1 site

Monell Chemical Senses Center
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

This proposal describes a pilot study aimed at determining whether genetic variations in taste receptors determine differential taste tolerability of pediatric medications.

Read the detailed description

This is a cross-sectional call-back study of taste perception and the relationship between taste perception and taste receptor genotype.

Conditions: Healthy
Keywords: Bitter Taste, Pediatric Medications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01841710
Study group	Role	What they receive
Women		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Psychophysical data for taste solutions
Primary outcome variables are intensity ratings of pediatric medications as well as a variety of generally recognized as safe bitter and non-bitter compounds.
Measured: 1-2 hours

Secondary outcomes (1)

Maternal practices and perceptions of medication use
Secondary outcome variables include questions related to maternal practices and perceptions of medication use and compliance of their children.
Measured: 1-2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2012Dec 2015

First posted26 Apr 2013 (estimated)
Study startDec 2012
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)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: Cohort
Time perspective: Cross-sectional
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01841710
Sponsor's protocol ID: 816980
Other IDs: R01DC011287
Status last verified: Mar 2016
First submitted: 24 Apr 2013
Last updated: 16 Mar 2016
Results posted: No
Data monitoring committee: No

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 28923290

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Genetic Variability in Taste Perception
ClinicalTrials.gov ID: NCT01841710
Acronym / sponsor ID: 816980
Conditions: Healthy
Keywords: Bitter Taste, Pediatric Medications
Study type: Observational
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Monell Chemical Senses CenterUniversity, hospital or other
Collaborators: Children's Hospital of Philadelphia, University of Pennsylvania, National Institute on Deafness and Other Communication Disorders (NIDCD)
Study start: Dec 2012
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 26 Apr 2013 (estimated)
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.

This proposal describes a pilot study aimed at determining whether genetic variations in taste receptors determine differential taste tolerability of pediatric medications.

Detailed description

This is a cross-sectional call-back study of taste perception and the relationship between taste perception and taste receptor genotype.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Women	–	–

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: One hundred women who were previously enrolled in the study entitled "Efficacy of Bitter Blockers on Taste Acceptance in Pediatric Populations," Protocol #809789; will be recruited for the current study

Key inclusion criteria (1 listed)

Adult females who were previously enrolled in Efficacy of Bitter Blockers on Taste Acceptance in Pediatric Populations Study (Protocol #809789)

Key exclusion criteria (2 listed)

Women who are pregnant
Women on drugs with potential serious adverse effects that are mediated through cytochrome P450.

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

Psychophysical data for taste solutions
Time frame: 1-2 hours
Primary outcome variables are intensity ratings of pediatric medications as well as a variety of generally recognized as safe bitter and non-bitter compounds.

1 secondary outcome

Maternal practices and perceptions of medication use
Time frame: 1-2 hours

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 16 Mar 2016.
Derived from this study: 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.

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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 MSCE principal investigator

University of Pennsylvania

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 2 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 16 Mar 2016. 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?

Psychophysical data for taste solutions (time frame: 1-2 hours). 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 NCT01841710, which also lists 1 linked publication.

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 16 Mar 2016; AzTrials last refreshed its copy on 30 Oct 2026.