- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03506074
Flavor Test Results in General Population
Flavor Perception in the Population of Campania Region, Italy
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Age ≥ 18 years
Exclusion Criteria:
Allergies, drug usage
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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). |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Immediately after the test administration flavor score was calculated
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paolo E. Macchia, M.D., Ph.D., Dipartimento Medicina Clinica e Chirurgia, Università degli Studi di Napoli Federico II
Publications and helpful links
General Publications
- 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.
- Nettore IC, Maione L, Palatucci G, Dolce P, Franchini F, Ungaro P, Belfiore A, Colao A, Macchia PE. Flavor identification inversely correlates with body mass index (BMI). Nutr Metab Cardiovasc Dis. 2020 Jul 24;30(8):1299-1305. doi: 10.1016/j.numecd.2020.04.005. Epub 2020 Apr 20.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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