ObesityTASTEOBNCT05772052
Abnormal Eating and Taste Perception in Subjects With Obesity
An observational study of Obesity, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
The identification of safe and effective strategies for weight loss and long-term maintenance is critical to reduce the alarming prevalence of obesity worldwide and mitigate obesity-associated health risks. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 2 Nov 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects with obesity referred to Istituto Auxologico Italiano for weight loss program
Who may be able to join
- BMI>30 kg/m2 and <45 kg/m2
Who cannot join
- uncooperative patients
- heavy smokers
- pregnancy or recent (in the last 6 months) childbirth
- thyroid disorders
- presence of endocrine abnormalities associated with obesity
- current or recent oral, nasal or sinus infections
- major psychiatric disorder even in pharmacological compensation
- patients who had undergone bariatric surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano
Milan, 20145
Luisa Gilardini, MD, 0261911 ext. 2561, l.gilardini@auxologico.it
About this study
Official title: Food Addiction, Binge Eating Disorder and Taste Perception in Subjects With Obesity
The identification of safe and effective strategies for weight loss and long-term maintenance is critical to reduce the alarming prevalence of obesity worldwide and mitigate obesity-associated health risks. Specifically, Binge Eating (BE) and Food Addiction (FA) behaviors are well known causes of failed weight loss and weight regain. The definitions of their clinical phenotypes are currently evolving. Recent evidence suggests that food choices, behavior and reward may be driven also by taste perception.
The hypothesis of this study is that subjects with dysfunctional eating behavior have different taste thresholds compared to obese subjects without eating disorders, and that this characteristic influences food choice and eating behavior. Identifying a difference in the taste thresholds between obese with and without eating disorder will allow us to understand why certain individuals over-consume or binge on densely caloric foods and to give them a tailored dietary treatment so as to maintain weight loss for a long time.
The Binge eating and Food Addiction is assessed using Binge Eating Scale and Yale Food Addiction Scale 2.0. Subjects with obesity recruited are divided in 4 groups: without eating disorder, with food addiction (FA), with binge eating (BE) and with FA + BE. In these groups sweet and salty taste will be measured with the 3-Alternative-Forced-Choice method.
- Conditions
- Obesity
- Keywords
- Taste; Obesity; Food addiction; Binge eating; sweet; salty
- Medical subject headings
- Obesity, Food Addiction, Bulimia
What is being measured
The primary outcome is the main question the study is designed to answer.
sweet taste recognition threshold
The sweet taste recognition threshold is assessed in subjects without eating disorders, with FA,with BE and FA+ BE
Measured: baseline
salt taste recognition threshold
The salt taste recognition threshold is assessed in subjects without eating disorders, with FA,with BE and FA+ BE
Measured: baseline
Secondary outcomes (3)
prevalence of binge eating (BE)
percentage of subjects recruited with BE
Measured: baseline
prevalence of Food Addiction (FA)
percentage of subjects recruited with FA
Measured: baseline
prevalence of Food Addiction (FA) + Binge Eating (BE)
percentage of subjects recruited with FA+BE
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start2 Nov 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simona Bertoli, MD, Study chair, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772052
- Sponsor's protocol ID
- 43C002
- Acronym
- TASTEOB
- Status last verified
- Sep 2025
- First submitted
- 6 Mar 2023
- Last updated
- 3 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aloi M, Rania M, Rodriguez Munoz RC, Jimenez Murcia S, Fernandez-Aranda F, De Fazio P, Segura-Garcia C. Validation of the Italian version of the Yale Food Addiction Scale 2.0 (I-YFAS 2.0) in a sample of undergraduate students. Eat Weight Disord. 2017 Sep;22(3):527-533. doi: 10.1007/s40519-017-0421-x. Epub 2017 Aug 5.
PubMed 28780748Arlt JM, Smutzer GS, Chen EY. Taste assessment in normal weight and overweight individuals with co-occurring Binge Eating Disorder. Appetite. 2017 Jun 1;113:239-245. doi: 10.1016/j.appet.2017.02.034. Epub 2017 Feb 24.
PubMed 28242311Bertoli S, Leone A, Ponissi V, Bedogni G, Beggio V, Strepparava MG, Battezzati A. Prevalence of and risk factors for binge eating behaviour in 6930 adults starting a weight loss or maintenance programme. Public Health Nutr. 2016 Jan;19(1):71-7. doi: 10.1017/S1368980015001068. Epub 2015 May 11.
PubMed 25958773Proserpio C, Laureati M, Bertoli S, Battezzati A, Pagliarini E. Determinants of Obesity in Italian Adults: The Role of Taste Sensitivity, Food Liking, and Food Neophobia. Chem Senses. 2016 Feb;41(2):169-76. doi: 10.1093/chemse/bjv072. Epub 2015 Dec 15.
PubMed 26671250
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Addiction, Binge Eating Disorder and Taste Perception in Subjects With Obesity
- ClinicalTrials.gov ID
- NCT05772052
- Acronym / sponsor ID
- TASTEOB / 43C002
- Conditions
- Obesity
- Keywords
- Taste; Obesity; Food addiction; Binge eating; sweet; salty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Mar 2023 (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.
The identification of safe and effective strategies for weight loss and long-term maintenance is critical to reduce the alarming prevalence of obesity worldwide and mitigate obesity-associated health risks. Specifically, Binge Eating (BE) and Food Addiction (FA) behaviors are well known causes of failed weight loss and weight regain. The definitions of their clinical phenotypes are currently evolving. Recent evidence suggests that food choices, behavior and reward may be driven also by taste perception.
The hypothesis of this study is that subjects with dysfunctional eating behavior have different taste thresholds compared to obese subjects without eating disorders, and that this characteristic influences food choice and eating behavior. Identifying a difference in the taste thresholds between obese with and without eating disorder will allow us to understand why certain individuals over-consume or binge on densely caloric foods and to give them a tailored dietary treatment so as to maintain weight loss for a long time.
The Binge eating and Food Addiction is assessed using Binge Eating Scale and Yale Food Addiction Scale 2.0. Subjects with obesity recruited are divided in 4 groups: without eating disorder, with food addiction (FA), with binge eating (BE) and with FA + BE. In these groups sweet and salty taste will be measured with the 3-Alternative-Forced-Choice method.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects with obesity referred to Istituto Auxologico Italiano for weight loss program
Key inclusion criteria (1 listed)
- BMI>30 kg/m2 and <45 kg/m2
Key exclusion criteria (8 listed)
- uncooperative patients
- heavy smokers
- pregnancy or recent (in the last 6 months) childbirth
- thyroid disorders
- presence of endocrine abnormalities associated with obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sweet taste recognition threshold
Time frame: baseline
The sweet taste recognition threshold is assessed in subjects without eating disorders, with FA,with BE and FA+ BE
salt taste recognition threshold
Time frame: baseline
The salt taste recognition threshold is assessed in subjects without eating disorders, with FA,with BE and FA+ BE
3 secondary outcomes
prevalence of binge eating (BE)
Time frame: baseline
prevalence of Food Addiction (FA)
Time frame: baseline
prevalence of Food Addiction (FA) + Binge Eating (BE)
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Background: PubMed 28780748Aloi M, Rania M, Rodriguez Munoz RC, Jimenez Murcia S, Fernandez-Aranda F, De Fazio P, Segura-Garcia C. Validation of the Italian version of the Yale Food Addiction Scale 2.0 (I-YFAS 2.0) in a sample of undergraduate students. Eat Weight Disord. 2017 Sep;22(3):527-533. doi: 10.1007/s40519-017-0421-x. Epub 2017 Aug 5.
- Background: PubMed 28242311Arlt JM, Smutzer GS, Chen EY. Taste assessment in normal weight and overweight individuals with co-occurring Binge Eating Disorder. Appetite. 2017 Jun 1;113:239-245. doi: 10.1016/j.appet.2017.02.034. Epub 2017 Feb 24.
- Background: PubMed 25958773Bertoli S, Leone A, Ponissi V, Bedogni G, Beggio V, Strepparava MG, Battezzati A. Prevalence of and risk factors for binge eating behaviour in 6930 adults starting a weight loss or maintenance programme. Public Health Nutr. 2016 Jan;19(1):71-7. doi: 10.1017/S1368980015001068. Epub 2015 May 11.
- Background: PubMed 26671250Proserpio C, Laureati M, Bertoli S, Battezzati A, Pagliarini E. Determinants of Obesity in Italian Adults: The Role of Taste Sensitivity, Food Liking, and Food Neophobia. Chem Senses. 2016 Feb;41(2):169-76. doi: 10.1093/chemse/bjv072. Epub 2015 Dec 15.
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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.
Simona Bertoli, MD study chair
Istituto Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Istituto Auxologico Italiano at 1 site in Italy.
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 8 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: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luisa Gilardini, MF (+0261911 ext. 2561, l.gilardini@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sweet taste recognition threshold (time frame: baseline). The study lists 2 primary outcomes in all. 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 NCT05772052, which also lists 4 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 3 Oct 2025.