The Sense of Small and Inhibition in Obesity

Obesity Clinical Trial

— Smell_OB  

Official title:

Investigating the Relationship Between the Sense of Smell and Cognitive Inhibition in Obesity: a Behavioural Experiment.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05768672
• Other study ID #: 21C221
• Status: Recruiting
• Start date: January 10, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2023
• Source: Istituto Auxologico Italiano
• Contact: Federica Scarpina, PhD
• Phone: +39032351
• Email: f.scarpina[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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 content) of foods associated with odours.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

Inclusion criteria:

• Right-handed

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

Exclusion criteria:

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Experimental Task
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.

Locations

Country	Name	City	State
Italy	IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe	Piancavallo	VCO

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano	Università degli Studi di Trento

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	baseline