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NCT Number: NCT06855251

SENSing Inner BodiLy State: Understanding the Role of Interoception in obEsity

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.

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Key information

Conditions

Obesity Body Representation Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe

Piancavallo, VCO, 28824, Italy

Location status: Recruiting

Location contact

Federica Scarpina, PhD

CONTACT

[email protected]

+39032351 ext. 4003

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Right-handed individuals diagnosed with obesity
  • In rehabilitative treatment at the Istituto Auxologico

Exclusion criteria

  • Concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders

Treatment and study plan

The crossmodal dual-task

Behavioral

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.

Primary outcomes

  1. Visual detection velocity

    Time frame: At the moment of the experiment

    Reaction Time in milliseconds only for the valid responses in the visual task

  2. 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

Secondary outcomes

  1. Visual detection accuracy

    Time frame: At the moment of the experiment

    Percentage of the correct answers in the "No-Go" trials in the visual task.

Study contacts

Contact information is provided by the study sponsor or research team.

Federica Scarpina, PhD

CONTACT

[email protected]

+39032351 ext. 4353

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Acronym: SENSIBLE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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