NCT03506074

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
420

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

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, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 23, 2018

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

3.1 years

First QC Date

April 13, 2018

Last Update Submit

April 23, 2018

Conditions

Keywords

ObesityFlavor

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

Flavor testDIAGNOSTIC_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.

General population

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • Age ≥ 18 years

You may not qualify if:

  • Allergies, drug usage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 26209039BACKGROUND
  • 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.

MeSH Terms

Conditions

Body WeightSmokingObesity

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Paolo E. Macchia, M.D., Ph.D.

    Dipartimento Medicina Clinica e Chirurgia, Università degli Studi di Napoli Federico II

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

April 13, 2018

First Posted

April 23, 2018

Study Start

October 1, 2014

Primary Completion

October 30, 2017

Study Completion

October 30, 2017

Last Updated

April 24, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share