- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01399944
The Molecular Basis for a Broad Range of Phenotypes Related to hTAS2R38
December 14, 2017 updated by: Julie A. Mennella, Monell Chemical Senses Center
This single-site, within-subject, experimental study is designed to test the hypothesis that individuals express taste receptors differently and have different sensitivities to bitter taste samples, which results from uneven expression.
Subjects will include 100 racially and ethnically diverse, healthy adults.
All subjects will provide saliva samples for genetic analysis and undergo taste testing with common psychophysical stimuli.
From the pool of 100 subjects, 36 subjects from the common heterozygous group (PAV/AVI) and two from each homozygous group (AVI/AVI, nontaster and PAV/PAV, taster) will be invited to return for two additional sessions.
During both sessions the investigators will 1) measure bitterness thresholds for PROP, a common psychophysical stimulus; 2) measure bitterness perception of several vegetables; 3) obtain a saliva sample and 4) collect taste papillae.
The investigators will then isolate DNA and RNA from the taste papillae and isolate DNA from saliva to evaluate molecular differences over time and between individuals and how it relates to taste psychophysics.
All psychophysical and cellular measurements will be done during both sessions so that the investigators can determine how much variation is observed over a one-week time period in both cellular phenotype and psychophysical phenotype.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Monell Chemical Senses Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adults of all races and both genders (N=100) will be involved in the proposed research.
Typically, our population of subjects is approximately 45% African American, 45% Caucasian, 6% Hispanic, and 4% Asian.
This increased representation of under-represented minorities in our subject populations is reflective of the greater Philadelphia region and has been achieved, in part, through our outreach efforts advertising in local newspapers throughout the city.
Description
Inclusion Criteria:
- Key inclusion criteria include age 18-40 years; English speaking, and good health at the time of study participation.
Exclusion Criteria:
- Key exclusion criteria include cigarette smoking, which alters taste perception, oral disease and subjects undergoing Coumadin therapy. Subjects showing signs of oral disease, including tongue lesions or xerostomia will be excluded from tongue biopsy and therefore excluded from the study. Subjects undergoing Coumadin therapy will be excluded from tongue biopsy due to the risk of bleeding, and therefore excluded from the study. Subjects will not be excluded because of economic status, gender, race or ethnicity.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bitter taste thresholds
Time Frame: 2 days of testing (2 hours each)
|
Thresholds for propylthiouracil (PROP) will be measured using modified Harris-Kalmus recognition thresholds.
|
2 days of testing (2 hours each)
|
Taste intensity and hedonic ratings of vegetables
Time Frame: 3 days of testing (1-2 hours each)
|
Subjects will rate the intensity of five basic taste qualities (bitter, salt, sweet, sour, umami) and the liking of PROP, urea, quinine, caffeine, denatonium solutions and pureed vegetables using the general labelled magnitude scale (gLMS)
|
3 days of testing (1-2 hours each)
|
TAS2R Genotype
Time Frame: 1 day of testing (1-1.5 hours)
|
Genotype of several TAS2Rs will be determined from DNA extracted from a saliva sample.
|
1 day of testing (1-1.5 hours)
|
mRNA expression levels
Time Frame: 2 days of testing (2 hours each)
|
Expression of taste and related genes will be determined from mRNA extracted from human taste tissue obtained via tongue biopsy.
|
2 days of testing (2 hours each)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dietary habits
Time Frame: 2 days (2 hours each)
|
Subjects will complete a 24 hour diet recall on 2 days of testing.
|
2 days (2 hours each)
|
biometrics
Time Frame: 1 day (1-1.5 hours)
|
Height, weight, blood pressure and bioimpedance measurements will be taken.
|
1 day (1-1.5 hours)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Julie A. Mennella, PhD, Monell Chemical Senses Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
July 20, 2011
First Submitted That Met QC Criteria
July 21, 2011
First Posted (Estimate)
July 22, 2011
Study Record Updates
Last Update Posted (Actual)
December 18, 2017
Last Update Submitted That Met QC Criteria
December 14, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 813211
- F32DC011975-01A1 (U.S. NIH Grant/Contract)
- R01DC011287-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet