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Flavor Test Results in General Population

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ClinicalTrials.gov Identifier: NCT03506074
Recruitment Status : Completed
First Posted : April 23, 2018
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Paolo Emidio Macchia, Federico II University

Brief 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.


Condition or disease Intervention/treatment
Weight, Body Smoking Age Problem Diagnostic Test: Flavor test

Detailed 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.


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Study Type : Observational
Actual Enrollment : 420 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Flavor Perception in the Population of Campania Region, Italy
Actual Study Start Date : October 1, 2014
Actual Primary Completion Date : October 30, 2017
Actual Study Completion Date : October 30, 2017

Group/Cohort Intervention/treatment
General population

Adult volunteers (≥18 years of age) selected as part of a project to investigate the role of lifestyle in preventing chronic diseases supported by the Campus Salute association (www.campussalute.it).

All volunteers performed the flavor test as described in Maione et al, Endocrine, 2016 (doi:10.1007/s12020-015-0690-y).

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.




Primary Outcome Measures :
  1. Flavor score [ Time Frame: Immediately after the test administration flavor score was calculated ]
    A flavor score (1-21) was measured in all the studied subjects using the Flavor test



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
General population volunteerly selected during a project to investigate the role of lifestyle in preventing chronic diseases supported by the Campus Salute association (www.campussalute.it).
Criteria

Inclusion Criteria:

Age ≥ 18 years

Exclusion Criteria:

Allergies, drug usage


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506074


Sponsors and Collaborators
Federico II University
Investigators
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Principal Investigator: Paolo E. Macchia, M.D., Ph.D. Dipartimento Medicina Clinica e Chirurgia, Università degli Studi di Napoli Federico II

Publications:
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Responsible Party: Paolo Emidio Macchia, Prof., Federico II University
ClinicalTrials.gov Identifier: NCT03506074     History of Changes
Other Study ID Numbers: PM0001/18
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paolo Emidio Macchia, Federico II University:
Obesity
Flavor
Additional relevant MeSH terms:
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Body Weight
Signs and Symptoms