NCT01399944

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

December 18, 2017

Status Verified

December 1, 2017

Enrollment Period

1.9 years

First QC Date

July 20, 2011

Last Update Submit

December 14, 2017

Conditions

Keywords

bitter tastepsychophysicsgeneticsepigeneticsbitterness sensitivity

Outcome Measures

Primary Outcomes (4)

  • Bitter taste thresholds

    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

    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

    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

    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 Outcomes (2)

  • Dietary habits

    2 days (2 hours each)

  • biometrics

    1 day (1-1.5 hours)

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monell Chemical Senses Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and taste tissue will be collected from individuals enrolled in the study.

Study Officials

  • Julie A. Mennella, PhD

    Monell Chemical Senses Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Member

Study Record Dates

First Submitted

July 20, 2011

First Posted

July 22, 2011

Study Start

July 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

December 18, 2017

Record last verified: 2017-12

Locations