- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01097915
Gustin Gene Polymorphism and 6-n-propylthiouracil (PROP) Taste (gustinprop)
Sensitivity to 6-n-propylthiouracil (PROP) Association With Gustin (CA6) Gene Polymorphism, Salivary Zinc and BMI in Humans
Study Overview
Status
Conditions
Detailed Description
The investigators evaluate the possible association of PROP taste with gustin gene polymorphism rs2274333 (A/G), salivary zinc ion concentration and BMI.
Furthermore, we apply direct measures of the gustatory system activation following stimulation with PROP, obtained by electrophysiological recordings from the tongue of subjects classified for taster status, genotyped for the specific receptor gene (TAS2R38), and in which papilla density was determined.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ca
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Cagliari, Ca, Italy, 09124
- Sezione di Farmacologia Clinica del Dipartimento di Neuroscienze, San Giovanni di Dio Azienda Ospedaliero Universitaria di Cagliari
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- no variation of body weight > 5 kg over the last 3 mo BMI within 20-25 Age between 20-30
Exclusion Criteria:
- gustatory impairment following a prescribed diet or using medications that might interfere with taste perception food allergies smokers
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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PROP taste sensitivity
PROP Sensitive and non sensitive individuals are defined as "Tasters" and "Non-tasters", respectively.
Taster are further divided in "Super-taster" who perceived PROP as extremely bitter and "Medium tasters" who perceived PROP as moderately bitter.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Association Between Gustin Gene Polymorphism and PROP Sensitivity
Time Frame: 7 months
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We examine associations between PROP status and the polymorphism rs2274333 (A/G) of the gene that codify for the salivary protein, gustin/CA6, Which has been suggested as a trophic factor that promotes growth and development of taste buds by acting on taste bud stem cells. The intensity of taste perception evoked by PROP and NaCl solutions was estimated to evaluate PROP taster status and molecular analysis of the gustin gene polymorphism was performed in individuals classified by PROP status using PCR techniques. |
7 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Association Between PROP Sensitivity and Saliva Zinc Ion Concentration
Time Frame: 7 months
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Since the enzymatic function of gustin (CA6) depends upon the presence of Zn at its active site we measured the salivary zinc ion concentration in subjects classified as super-taster, medium taster and non-taster.The salivary Zn2+ concentration was measured with a QuantiChromTM zinc Assay kit (Gentaur, Brussels, Belgium) where the color intensity is directly proportional to the Zn2+ concentration in the sample.
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7 months
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Association Between PROP Sensitivity and BMI
Time Frame: 7 months
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Since individual ability to taste PROP may be correlated with BMI, we determined BMI (kg/m^2) in subjects classified as super-taster, medium taster and non-taster.Weight (kg) and height (m) were recorded for each subject.
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7 months
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Electrophysiological Recordings From the Tongue for the Objective Evaluation of Individual Variations of 6-n-propylthiouracil (PROP) Sensitivity
Time Frame: 1 year
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electrophysiological recordings from the tongue of 43 subjects classified for their taste sensitivity to 6-n- propyltiouracil (PROP) and genotyped for the specific receptor gene, TAS2R38.
Density of fungiform papillae was also determined in each subject.
The biopotentials were recorded by means of differential electrophysiological derivations between two silver electrodes, one in contact with the ventral surface of the tongue and one in perfect adhesion with the dorsal surface.
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1 year
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Association Between PROP Sensitivity and Fungiform Papilla Density
Time Frame: 6 months
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43 subjects were classified for their taste sensitivity to 6-n- propyltiouracil (PROP) and density of fungiform papillae was determined in each subject.
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6 months
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Taste Perception of Sweet, Sour, Salty, Bitter and Umami and Changes Due to L-Arginine Supplementation, as a Functin of Genetic Ability to Taste PROP.
Time Frame: 8 months
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Taste perception was assessed by testing the ability to recognize, and the responsiveness to, representative solutions of the five taste qualities, also when supplemented with L-Arg, in subjects classified as PROP-tasters.
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8 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Iole Tomassini Barbarossa, PhD, Dip. Scienze Biomediche Sezione di Fisiologia Università di Cagliari
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNICADBSITB-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
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