Dysgeusia Clinical Trial
— gustinpropOfficial title:
Sensitivity to 6-n-propylthiouracil (PROP) Association With Gustin (CA6) Gene Polymorphism, Salivary Zinc and BMI in Humans
NCT number | NCT01097915 |
Other study ID # | UNICADBSITB-1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2009 |
Est. completion date | June 2016 |
Verified date | December 2018 |
Source | University of Cagliari |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The investigators evaluate the possible association of PROP taste with gustin gene polymorphism rs2274333 (A/G), salivary zinc ion concentration and BMI. In addition, it has also been evaluated PROP taste sensitivity by recording monophasic potentials from the tongue.
Status | Completed |
Enrollment | 170 |
Est. completion date | June 2016 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 30 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Sezione di Farmacologia Clinica del Dipartimento di Neuroscienze, San Giovanni di Dio Azienda Ospedaliero Universitaria di Cagliari | Cagliari | Ca |
Lead Sponsor | Collaborator |
---|---|
University of Cagliari |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Association Between Gustin Gene Polymorphism and PROP Sensitivity | 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 | |
Secondary | Association Between PROP Sensitivity and Saliva Zinc Ion Concentration | 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. | 7 months | |
Secondary | Association Between PROP Sensitivity and BMI | 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. | 7 months | |
Secondary | Electrophysiological Recordings From the Tongue for the Objective Evaluation of Individual Variations of 6-n-propylthiouracil (PROP) Sensitivity | 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. | 1 year | |
Secondary | Association Between PROP Sensitivity and Fungiform Papilla Density | 43 subjects were classified for their taste sensitivity to 6-n- propyltiouracil (PROP) and density of fungiform papillae was determined in each subject. | 6 months | |
Secondary | 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. | 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. | 8 months |
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