Weight, BodyNCT03506074
Flavor Test Results in General Population
An observational study of Weight, Body and Smoking, run by Federico II University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight, Body, Smoking, Age Problem
- What is being tested?
- Flavor test
- How many people
- 420 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2014to 30 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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).
Who may be able to join
- Age ≥ 18 years
Who cannot join
- Allergies, drug usage
About this study
Official title: 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.
Read the 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.
- Conditions
- Weight, Body, Smoking, Age Problem
- Being tested
- Flavor test
- Keywords
- Obesity, Flavor
- Medical subject headings
- Body Weight, Smoking, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Flavor test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flavor score
A flavor score (1-21) was measured in all the studied subjects using the Flavor test
Measured: Immediately after the test administration flavor score was calculated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start1 Oct 2014
- Primary completion30 Oct 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Weight, BodyStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Emidio Macchia, Federico II University
- Investigators
- Paolo E. Macchia, M.D., Ph.D., Principal investigator, Dipartimento Medicina Clinica e Chirurgia, Università degli Studi di Napoli Federico II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506074
- Sponsor's protocol ID
- PM0001/18
- Status last verified
- Apr 2018
- First submitted
- 13 Apr 2018
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26209039Nettore 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.
PubMed 32513578
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flavor Perception in the Population of Campania Region, Italy
- ClinicalTrials.gov ID
- NCT03506074
- Acronym / sponsor ID
- PM0001/18
- Conditions
- Weight, Body, Smoking, Age Problem
- Keywords
- Obesity, Flavor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 23 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General population | – | Diagnostic Test: Flavor testAdult 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Age ≥ 18 years
Key exclusion criteria (1 listed)
- Allergies, drug usage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flavor testThe 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. | Diagnostic test | General population |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Background: PubMed 26209039Maione 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.
- Derived from this study: PubMed 32513578Nettore 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo E. Macchia, M.D., Ph.D. principal investigator
Dipartimento Medicina Clinica e Chirurgia, Università degli Studi di Napoli Federico II
Questions about this trial
What is this clinical trial studying?
An observational study of Weight, Body and Smoking, run by Federico II University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flavor score (time frame: Immediately after the test administration flavor score was calculated). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03506074, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2018.