- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04662606
Neurofunctional Correlates of Intentional Actions Towards Food Stimuli
December 9, 2020 updated by: Istituto Ortopedico Galeazzi
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Fasting-group
|
|
Experimental: Fed-group
|
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
Time Frame: This outcome will be measured on the recruitment day
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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