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The Molecular Basis for a Broad Range of Phenotypes Related to hTAS2R38

NCT ID: NCT01399944

Last Updated: 2017-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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bitter taste psychophysics genetics epigenetics bitterness sensitivity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

Monell Chemical Senses Center

OTHER

Sponsor Role lead

Responsible Party

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Julie A. Mennella

Member

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julie A. Mennella, PhD

Role: PRINCIPAL_INVESTIGATOR

Monell Chemical Senses Center

Locations

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Monell Chemical Senses Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Lipchock SV, Mennella JA, Spielman AI, Reed DR. Human bitter perception correlates with bitter receptor messenger RNA expression in taste cells. Am J Clin Nutr. 2013 Oct;98(4):1136-43. doi: 10.3945/ajcn.113.066688. Epub 2013 Sep 11.

Reference Type DERIVED
PMID: 24025627 (View on PubMed)

Other Identifiers

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F32DC011975-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01DC011287-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

813211

Identifier Type: -

Identifier Source: org_study_id