ObesitySmell_OBNCT05768672
The Sense of Small and Inhibition in Obesity
An observational study of Obesity, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
The aim of this research is to verify whether inhibitory control ability is different between a group of individuals with obesity and a group of individuals with normal weight in the presence of olfactory stimuli, different for valence, edibility (food versus no-food), and caloric density (high-calorie vs low-calorie… Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Experimental Task
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2023to 30 Jun 2024
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants with obesity will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy)
Who may be able to join
- Right-handed
- diagnosis of obesity (i.e., the level of body mass index (BMI) higher or equal to 30).
Who cannot join
- Concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe
Piancavallo, VCO, 28824
About this study
Official title: Investigating the Relationship Between the Sense of Smell and Cognitive Inhibition in Obesity: a Behavioural Experiment.
The aim of this research is to verify whether inhibitory control ability is different between a group of individuals with obesity and a group of individuals with normal weight in the presence of olfactory stimuli, different for valence, edibility (food versus no-food), and caloric density (high-calorie vs low-calorie content) of foods associated with odours.
- Conditions
- Obesity
- Being tested
- Experimental Task
- Keywords
- obesity, smell, food, cognitive inhibition
- Medical subject headings
- Obesity, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental TaskBehavioural
The main task is an olfactory version of a traditional Go/No-Go task (Albayay et al., 2019): it includes the delivery of either an odour or clean air prior to the presentation of a visual target Moreover, all participants will be assessed with the italian version of the Stroop color and word test (Caffarra et al., 2004) to evaluate inhibition, together with selective and sustained attention. This neuropsychological test consists of three tables, showing color words (W), colored circles (C), and color words printed in incongruent ink (i.e., red printed in blue ink, CW), respectively. The Stroop effect consists of a delayed response when words have to be named according to the color of the ink, ignoring the meaning of the printed word.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Right-handed Individuals diagnosed with obesity will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). Receives: Behavioral: Experimental Task | |
| Controls | Age-matched, right-handed, individuals with a healthy weight recruited outside the hospital through personal contacts of the researchers and word-of-mouth Receives: Behavioral: Experimental Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Error %
Percentage of the invalid answers, meaning when the participant erroneously press the key (i.e., answer) in the no-go (invalid) trials. This represents an index of inhibitory difficulty in the experimental task. This score will be computed according to Albayay and colleagues (2019).
Measured: baseline
Secondary outcomes (1)
Interference Error
It will computed according to the following formula:
score = CW - ((W + C)/2). The lower is the score, the best is the performance. Notably for each condition (W, C, and CW) the number of error can range from O (no error) to 36 (maximun number of error). This computation derives from the seminal article for the Italian version of the test (Caffarra et al., 2004).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start10 Jan 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Trento
- Responsible party
- Sponsor
- Investigators
- Sofia Tagini, PhD, Principal investigator, IRCCS Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768672
- Sponsor's protocol ID
- 21C221
- Acronym
- Smell_OB
- Status last verified
- Aug 2025
- First submitted
- 22 Feb 2023
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Relationship Between the Sense of Smell and Cognitive Inhibition in Obesity: a Behavioural Experiment.
- ClinicalTrials.gov ID
- NCT05768672
- Acronym / sponsor ID
- Smell_OB / 21C221
- Conditions
- Obesity
- Keywords
- obesity, smell, food, cognitive inhibition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Collaborators
- Università degli Studi di Trento
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 14 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 aim of this research is to verify whether inhibitory control ability is different between a group of individuals with obesity and a group of individuals with normal weight in the presence of olfactory stimuli, different for valence, edibility (food versus no-food), and caloric density (high-calorie vs low-calorie content) of foods associated with odours.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Behavioral: Experimental TaskRight-handed Individuals diagnosed with obesity will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). |
| Controls | – | Behavioral: Experimental TaskAge-matched, right-handed, individuals with a healthy weight recruited outside the hospital through personal contacts of the researchers and word-of-mouth |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants with obesity will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy)
Key inclusion criteria (2 listed)
- Right-handed
- diagnosis of obesity (i.e., the level of body mass index (BMI) higher or equal to 30).
Key exclusion criteria (1 listed)
- Concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders.
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 |
|---|---|---|
| Experimental TaskThe main task is an olfactory version of a traditional Go/No-Go task (Albayay et al., 2019): it includes the delivery of either an odour or clean air prior to the presentation of a visual target Moreover, all participants will be assessed with the italian version of the Stroop color and word test (Caffarra et al., 2004) to evaluate inhibition, together with selective and sustained attention. This neuropsychological test consists of three tables, showing color words (W), colored circles (C), and color words printed in incongruent ink (i.e., red printed in blue ink, CW), respectively. The Stroop effect consists of a delayed response when words have to be named according to the color of the ink, ignoring the meaning of the printed word. | Behavioural | Cases, Controls |
Primary outcome
Error %
Time frame: baseline
Percentage of the invalid answers, meaning when the participant erroneously press the key (i.e., answer) in the no-go (invalid) trials. This represents an index of inhibitory difficulty in the experimental task. This score will be computed according to Albayay and colleagues (2019).
1 secondary outcome
Interference Error
Time frame: baseline
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 27 Aug 2025.
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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.
Sofia Tagini, PhD principal investigator
IRCCS 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 2 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 27 Aug 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?
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?
Error % (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2025.