Clinical trial NCT03506074: Flavor Test Results in General Population
Official title: Flavor Perception in the Population of Campania Region, Italy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight, Body
Smoking
Age Problem
Keywords: Obesity
Flavor
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2018-04-23
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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).

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.

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.

Eligibility criteria: Inclusion Criteria:

Age ≥ 18 years

Exclusion Criteria:

Allergies, drug usage

Primary outcomes:
measure: Flavor score
timeFrame: Immediately after the test administration flavor score was calculated
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dipartimento Medicina Clinica e Chirurgia, Università degli Studi di Napoli Federico II
name: Paolo E. Macchia, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.