NCT01097915

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2009

Longer than P75 for all trials

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

October 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2010

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
7 months until next milestone

Results Posted

Study results publicly available

December 21, 2016

Completed
Last Updated

December 21, 2018

Status Verified

December 1, 2018

Enrollment Period

2 months

First QC Date

April 1, 2010

Results QC Date

July 19, 2016

Last Update Submit

December 20, 2018

Conditions

Keywords

PROP taste sensitivityGustin (CAVI) polymorphismSalivary zincBMIElectrophysiological recording from the tongue

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Association Between PROP Sensitivity and Saliva Zinc Ion Concentration

    7 months

  • Association Between PROP Sensitivity and BMI

    7 months

  • Electrophysiological Recordings From the Tongue for the Objective Evaluation of Individual Variations of 6-n-propylthiouracil (PROP) Sensitivity

    1 year

  • Association Between PROP Sensitivity and Fungiform Papilla Density

    6 months

  • 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.

    8 months

Study Arms (1)

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.

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • no variation of body weight \> 5 kg over the last 3 mo BMI within 20-25 Age between 20-30

You may not qualify if:

  • gustatory impairment following a prescribed diet or using medications that might interfere with taste perception food allergies smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sezione di Farmacologia Clinica del Dipartimento di Neuroscienze, San Giovanni di Dio Azienda Ospedaliero Universitaria di Cagliari

Cagliari, Ca, 09124, Italy

Location

Related Publications (1)

  • Padiglia A, Zonza A, Atzori E, Chillotti C, Calo 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.

Biospecimen

Retention: SAMPLES WITH DNA

DNA and zinc analyses in saliva

MeSH Terms

Conditions

Dysgeusia

Condition Hierarchy (Ancestors)

Taste DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Iole Tomassini Barbarossa, Associate Professor
Organization
University of Cagliari

Study Officials

  • Iole Tomassini Barbarossa, PhD

    Dip. Scienze Biomediche Sezione di Fisiologia Università di Cagliari

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 1, 2010

First Posted

April 2, 2010

Study Start

October 1, 2009

Primary Completion

December 1, 2009

Study Completion

June 1, 2016

Last Updated

December 21, 2018

Results First Posted

December 21, 2016

Record last verified: 2018-12

Locations