Smell_OB: The Sense of Small and Inhibition in Obesity

Sponsor
Istituto Auxologico Italiano (Other)
Overall Status
Recruiting
CT.gov ID
NCT05768672
Collaborator
Università degli Studi di Trento (Other)
25
1
17.7
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Experimental Task

Study Design

Study Type:
Observational
Anticipated Enrollment :
25 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Investigating the Relationship Between the Sense of Smell and Cognitive Inhibition in Obesity: a Behavioural Experiment.
Actual Study Start Date :
Jan 10, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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
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.

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
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.

Outcome Measures

Primary Outcome Measures

  1. Error % [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).

Secondary Outcome Measures

  1. Interference Error [baseline]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe Piancavallo VCO Italy 28824

Sponsors and Collaborators

  • Istituto Auxologico Italiano
  • Università degli Studi di Trento

Investigators

  • Principal Investigator: Sofia Tagini, PhD, IRCCS Istituto Auxologico Italiano

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Istituto Auxologico Italiano
ClinicalTrials.gov Identifier:
NCT05768672
Other Study ID Numbers:
  • 21C221
First Posted:
Mar 14, 2023
Last Update Posted:
Mar 14, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Istituto Auxologico Italiano
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2023