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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04662606
Other study ID # CONSUME
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 12, 2020
Est. completion date December 1, 2022

Study information

Verified date December 2020
Source Istituto Ortopedico Galeazzi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this project, the investigators will explore the cognitive neuroscience of intentional action in relation to food behaviour. To unravel how the brain systems involved in intentional control of actions and how these interact with the reward system in different physiological conditions and in relation to lean-weight or obesity, the investigators will manipulate the degree of intentionality of the behaviours under examination and the level of satiety of the participants.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date December 1, 2022
Est. primary completion date September 12, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Normal weight (normal BMI) - No MRI controindications - No neurological or cognitive problems Exclusion Criteria: - Underweight or overweight - MRI controindications - Neurological or cognitive problems

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Consumption of a standard meal prior to the fMRI data collection
Consumption of a standard meal prior to the fMRI data collection

Locations

Country Name City State
Italy IRCCS Istituto Ortopedico Galeazzi Milan Milano
Italy IRCCS Galeazzi Milano Italia

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary BOLD (Blood Oxygen Level Dependent) signal The investigators will measure the changes of the hemodynamic response (BOLD signal) recorded in the whole brain during the execution of the different experimental tasks (e.g. intentionally guided actions towards stimuli of high or low calories food vs externally guided actions towards stimuli of high or low calories food), in the two groups (fasted and satiated subjects). This outcome will be measured on the recruitment day
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