Neurofunctional Correlates of Intentional Actions Towards Food Stimuli

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.

Study Overview

• Status: Unknown
• Conditions: Food Preferences
• Intervention / Treatment: Behavioral: Consumption of a standard meal prior to the fMRI data collection

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Italia
    • Milano, Italia, Italy, 20161
      • Recruiting
      • IRCCS Galeazzi
  • Milano
    • Milan, Milano, Italy, 20126
      • Recruiting
      • IRCCS Istituto Ortopedico Galeazzi
      • Contact: Laura Zapparoli, PhD; Phone Number: 390264483776; Email: laura.zapparoli@unimib.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Fasting-group
Experimental: Fed-group	Behavioral: Consumption of a standard meal prior to the fMRI data collection; Consumption of a standard meal prior to the fMRI data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Galeazzi

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2020
• Primary Completion (Anticipated): September 12, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 9, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CONSUME

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No