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Gustin Gene Polymorphism and 6-n-propylthiouracil (PROP) Taste (gustinprop)

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ClinicalTrials.gov Identifier: NCT01097915
Recruitment Status : Completed
First Posted : April 2, 2010
Results First Posted : December 21, 2016
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Iole Tomassini Barbarossa, University of Cagliari

Tracking Information
First Submitted Date April 1, 2010
First Posted Date April 2, 2010
Results First Submitted Date July 19, 2016
Results First Posted Date December 21, 2016
Last Update Posted Date December 21, 2018
Study Start Date October 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 26, 2016)
Association Between Gustin Gene Polymorphism and PROP Sensitivity [ Time Frame: 7 months ]
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.
Original Primary Outcome Measures
 (submitted: April 1, 2010)
Association Between Gustin Gene Polymorphism and PROP Sensitivity [ Time Frame: 7 months ]
Change History
Current Secondary Outcome Measures
 (submitted: December 20, 2018)
  • Association Between PROP Sensitivity and Saliva Zinc Ion Concentration [ Time Frame: 7 months ]
    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.
  • Association Between PROP Sensitivity and BMI [ Time Frame: 7 months ]
    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.
  • Electrophysiological Recordings From the Tongue for the Objective Evaluation of Individual Variations of 6-n-propylthiouracil (PROP) Sensitivity [ Time Frame: 1 year ]
    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.
  • Association Between PROP Sensitivity and Fungiform Papilla Density [ Time Frame: 6 months ]
    43 subjects were classified for their taste sensitivity to 6-n- propyltiouracil (PROP) and density of fungiform papillae was determined in each subject.
  • 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 ]
    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.
Original Secondary Outcome Measures
 (submitted: April 1, 2010)
association between PROP sensitivity, Saliva zinc ion concentration and BMI [ Time Frame: 7 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Gustin Gene Polymorphism and 6-n-propylthiouracil (PROP) Taste
Official Title Sensitivity to 6-n-propylthiouracil (PROP) Association With Gustin (CA6) Gene Polymorphism, Salivary Zinc and BMI in Humans
Brief Summary 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.
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 Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
DNA and zinc analyses in saliva
Sampling Method Probability Sample
Study Population Seventy-five non-smoking volunteers (28 men and 47 women) were recruited for the study. Participants between 20-30 years were eligible for the study. Thresholds for the 4 basic tastes were evaluated in all subjects in order to rule out any gustatory impairment. The volunteers showed no variation of body weight > 5 kg over the last 3 mo. They were not following a prescribed diet or using medications that might interfere with taste perception; none had food allergies. They were assessed for cognitive eating behaviours using the Three-Factor Eating Questionnaire
Condition Dysgeusia
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * Padiglia A, Zonza A, Atzori E, Chillotti C, Calò C, Tepper BJ, Barbarossa IT. Sensitivity to 6-n-propylthiouracil is associated with gustin (carbonic anhydrase VI) gene polymorphism, salivary zinc, and body mass index in humans. Am J Clin Nutr. 2010 Sep;92(3):539-45. doi: 10.3945/ajcn.2010.29418. Epub 2010 Jul 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 26, 2016)
170
Original Actual Enrollment
 (submitted: April 1, 2010)
75
Actual Study Completion Date June 2016
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 30 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT01097915
Other Study ID Numbers UNICADBSITB-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Data of this study are available from the principal investigator of this study upon request
Responsible Party Iole Tomassini Barbarossa, University of Cagliari
Study Sponsor University of Cagliari
Collaborators Not Provided
Investigators
Principal Investigator: Iole Tomassini Barbarossa, PhD Dip. Scienze Biomediche Sezione di Fisiologia Università di Cagliari
PRS Account University of Cagliari
Verification Date December 2018