Flavor Test Results in General Population

Smoking Clinical Trial

Official title:

Flavor Perception in the Population of Campania Region, Italy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03506074
• Other study ID #: PM0001/18
• Status: Completed
• First received: April 13, 2018
• Last updated: April 23, 2018
• Start date: October 1, 2014
• Est. completion date: October 30, 2017

Study information

• Verified date: April 2018
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Dietary choices are influenced by several factors, including physiological, social or genetic factors. Among these, flavor is the most important determinant modulating the preferences versus specific foods.

Flavor perception is the result from the sensory integration of taste and odor properties of food.

Aim of the present study was to assess flavor abilities in a large population using a validated perceptive test.

Description:

This protocol investigates flavor perception using the flavor test, a specific test to assess the retro-nasal olfactory function.

A decrease in taste and smell abilities can result in loss of appetite, inadequate dietary intake and malnutrition. Several diseases and conditions have been associated with taste disorders and a decline in gustatory function is very common in the elderly.

The flavor test was previously developed, validated and patented by our group. It consists of a series of 20 aromatic extracts, corresponding to routine dietary use flavors for Italian people.

Each tastant, originally stored in a 30 mL amber bottle, is diluted in distilled water and stored at 4 °C, then it is kept at room temperature for 20 min before administration.

An aliquot of approximately 0,5 mL of each tastant is administered in the oral cavity using a 3mL Transfer Pipet and left for approximately 5 seconds; the mouth is then rinsed twice with distilled water before the administration of the following tastant.

At each administration, participants are invited to identify the aromatic by making a choice from 5 proposed items. A total of 21 aromatics (including one blank) are administered sequentially. The flavor score (FS) is calculated as the sum of correctly identified aromatics and ranged from 0 to 21.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: October 30, 2017
• Est. primary completion date: October 30, 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Age = 18 years

Exclusion Criteria:

Allergies, drug usage

Related Conditions & MeSH terms

• Age Problem
• Body Weight
• Smoking
• Weight, Body

Intervention

Diagnostic Test:
• Flavor test
The flavor test was developed, validated and patented (patent no. 0001426253 of the Italian Ministry for the Economic Development). It consists of a series of 20 aromatic extracts, corresponding to routine dietary use flavors for Italian people. At each administration, participants were invited to identify the aromatic by making a choice from 5 proposed items. A total of 21 aromatics (including one blank) were administered sequentially. The flavor score (FS) was calculated as the sum of correctly identified aromatics and ranged from 0 to 21.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

References & Publications (1)

Maione L, Cantone E, Nettore IC, Cerbone G, De Brasi D, Maione N, Young J, Di Somma C, Sinisi AA, Iengo M, Macchia PE, Pivonello R, Colao A. Flavor perception test: evaluation in patients with Kallmann syndrome. Endocrine. 2016 May;52(2):236-43. doi: 10.1007/s12020-015-0690-y. Epub 2015 Jul 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flavor score	A flavor score (1-21) was measured in all the studied subjects using the Flavor test	Immediately after the test administration flavor score was calculated