ObesitySENSIBLENCT06855251
SENSing Inner BodiLy State: Understanding the Role of Interoception in obEsity
An observational study of Obesity and Body Representation, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
Successfully perceiving the flow of interoceptive cues and integrating them with exteroceptive information are fundamental aspects of countering the body's inherent instability and guaranteeing homeostatic regulation. This process deeply affects cognitive/emotional functioning and general health. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Body Representation
- What is being tested?
- The crossmodal dual-task
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2024to 30 Mar 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Participants with obesity were consecutively recruited during their rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy).
Who may be able to join
- Right-handed individuals diagnosed with obesity
- In rehabilitative treatment at the Istituto Auxologico
Who cannot join
- Concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders
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
IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe
Piancavallo, VCO, 28824
Federica Scarpina, PhD, +39032351 ext. 4003, f.scarpina@auxologico.it
About this study
Successfully perceiving the flow of interoceptive cues and integrating them with exteroceptive information are fundamental aspects of countering the body's inherent instability and guaranteeing homeostatic regulation. This process deeply affects cognitive/emotional functioning and general health. Recently, it has been suggested that an important signature underpinning obesity might be an interoceptive dysfunction in perceiving internal body signals and/or integrating them with information from the external environment. There is evidence that interoceptive deficits correlate with Body Mass Index (BMI), but it is still largely unclear how different measures and facets of interoception are related to high BMI and eating behaviour. Within this framework, it is mandatory to understand the role of interoception in obesity at perceptual, cognitive, and emotional levels. One open issue regards the relationships between interoceptive signals and the reactivity to external food cues.
- Conditions
- Obesity, Body Representation
- Being tested
- The crossmodal dual-task
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The crossmodal dual-taskBehavioural
Two main sensory tasks performed together:
- the visual task, in which participants are requested to monitor visual stimuli presented on a computer screen and to detect the "deviant" target" as soon as possible. The target changes across blocks: in half of the trials, participants will have to respond to food stimuli presented together with irrelevant non-food stimuli (food target condition); in the other half conditions, participants will have to respond to non-food stimuli presented together with irrelevant food stimuli (non-food target condition). For each participant, we will collect the Reaction Time in milliseconds only for the valid responses, and the level of Accuracy in percentage.
- The interoceptive task, in which participants are requested to monitor their heartbeat presented through headphones and registered through pulse oximetry. Participants will judge the level of asynchrony between their heartbeat and the auditory cue.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Right-handed women diagnosed with obesity are consecutively recruited during their rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). Concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders are exclusion criteria. Receives: Behavioral: The crossmodal dual-task | |
| Controls | Age-matched, right-handed, healthy women (i.e., with no history of eating disorders) are recruited outside the hospital through personal contacts of the researchers and word-of-mouth. Receives: Behavioral: The crossmodal dual-task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual detection velocity
Reaction Time in milliseconds only for the valid responses in the visual task
Measured: At the moment of the experiment
Interoceptive judgement
Individual's judgement from 0 (no synchronicity) to 100 (maximum synchronicity) between between the auditory stimulus and own heartbeat in the heartbeat detection task
Measured: At the moment of the experiment
Secondary outcomes (1)
Visual detection accuracy
Percentage of the correct answers in the "No-Go" trials in the visual task.
Measured: At the moment of the experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start1 Apr 2024
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Federica Scarpina, PhD, Principal investigator, IRCCS Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855251
- Sponsor's protocol ID
- 21C404
- Acronym
- SENSIBLE
- Status last verified
- Aug 2025
- First submitted
- 25 Feb 2025
- 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
- SENSing Inner BodiLy State: Understanding the Role of Interoception in obEsity
- ClinicalTrials.gov ID
- NCT06855251
- Acronym / sponsor ID
- SENSIBLE / 21C404
- Conditions
- Obesity, Body Representation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 3 Mar 2025 (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.
Successfully perceiving the flow of interoceptive cues and integrating them with exteroceptive information are fundamental aspects of countering the body's inherent instability and guaranteeing homeostatic regulation. This process deeply affects cognitive/emotional functioning and general health. Recently, it has been suggested that an important signature underpinning obesity might be an interoceptive dysfunction in perceiving internal body signals and/or integrating them with information from the external environment. There is evidence that interoceptive deficits correlate with Body Mass Index (BMI), but it is still largely unclear how different measures and facets of interoception are related to high BMI and eating behaviour. Within this framework, it is mandatory to understand the role of interoception in obesity at perceptual, cognitive, and emotional levels. One open issue regards the relationships between interoceptive signals and the reactivity to external food cues.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Behavioral: The crossmodal dual-taskRight-handed women diagnosed with obesity are consecutively recruited during their rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). Concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders are exclusion criteria. |
| Controls | – | Behavioral: The crossmodal dual-taskAge-matched, right-handed, healthy women (i.e., with no history of eating disorders) are recruited outside the hospital through personal contacts of the researchers and word-of-mouth. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants with obesity were consecutively recruited during their rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy).
Key inclusion criteria (2 listed)
- Right-handed individuals diagnosed with obesity
- In rehabilitative treatment at the Istituto Auxologico
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 |
|---|---|---|
| The crossmodal dual-taskTwo main sensory tasks performed together: 1. the visual task, in which participants are requested to monitor visual stimuli presented on a computer screen and to detect the "deviant" target" as soon as possible. The target changes across blocks: in half of the trials, participants will have to respond to food stimuli presented together with irrelevant non-food stimuli (food target condition); in the other half conditions, participants will have to respond to non-food stimuli presented together with irrelevant food stimuli (non-food target condition). For each participant, we will collect the Reaction Time in milliseconds only for the valid responses, and the level of Accuracy in percentage. 2) The interoceptive task, in which participants are requested to monitor their heartbeat presented through headphones and registered through pulse oximetry. Participants will judge the level of asynchrony between their heartbeat and the auditory cue. | Behavioural | Cases, Controls |
Primary outcome
Visual detection velocity
Time frame: At the moment of the experiment
Reaction Time in milliseconds only for the valid responses in the visual task
Interoceptive judgement
Time frame: At the moment of the experiment
Individual's judgement from 0 (no synchronicity) to 100 (maximum synchronicity) between between the auditory stimulus and own heartbeat in the heartbeat detection task
1 secondary outcome
Visual detection accuracy
Time frame: At the moment of the experiment
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 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.
Federica Scarpina, 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 and Body Representation, 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: looking for participants now, 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?
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 Federica Scarpina, PhD (+39032351 ext. 4353, f.scarpina@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual detection velocity (time frame: At the moment of the experiment). 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?
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.