The Sense of Small and Inhibition in Obesity

NCT05768672 | Completed

• 1 other identifier: 21C221
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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 content) of foods associated with odours.

Conditions

Obesity

Keywords

obesity; smell; food; cognitive inhibition

Outcome Measures

Primary Outcomes (1)

• 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).

  baseline

Secondary Outcomes (1)

• Interference Error

  baseline

Study Arms (2)

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).

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

Behavioral: Experimental Task

Interventions

Experimental Task BEHAVIORAL

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.

Cases; Controls

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• Right-handed
• diagnosis of obesity (i.e., the level of body mass index (BMI) higher or equal to 30).

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead
• Università degli Studi di Trento: collaborator

Study Sites (1)

IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe

Piancavallo, VCO, 28824, Italy

Location

MeSH Terms

Conditions

Obesity; Anosmia

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases

Study Officials

• Sofia Tagini, PhD

  IRCCS Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 14, 2023
• Study Start: January 10, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

IT (1)