Behavioral and Neurofunctional Correlates of Intentional Motor Behaviors Towards Edible Stimuli in Normal-weight Subjects

December 16, 2019 updated by: Istituto Ortopedico Galeazzi

This study aims to investigate, through behavioural tests combined with advanced neurofunctional methods, the neural bases of intentional behaviours towards edible stimuli using explicit and implicit paradigms in normal-weight subjects.

This knowledge will then be expanded with the study of associations between behavioral/neurofunctional measures and blood/hummon parameters.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Normal weight (Body mass index - BMI - comprised between 18.6 and 24.99.
  • Absence of usual contraindications to MRI examination (e.g. pacemakers, fixed hearing implants, presence of metallic foreign bodies, intrauterine bodies, metallic splinters or fragments, metallic prostheses, screws, nails, fixed or mobile dental prostheses).
  • Signature of informed consent and consent to cooperate in all study procedures.

Exclusion Criteria:

  • Previous diagnosis of significant neurological disorders (brain damage or dementia), major psychiatric disorders or eating disorders (binge-eating disorder, bulimia).
  • BMI less than 18.5 and greater than or equal to 25 Kg/cm2.
  • Serious medical conditions, including but not limited to: hypertension, significant heart disease, disorders or illnesses that may compromise patient safety.
  • Pregnancy and Claustrophobia.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Normal-weight subjects
Other: Neurofunctional imaging
Subjects will be submitted to a functional neuroimaging scanning procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BOLD Response
Time Frame: 3 years
We will record the BOLD response during the visualization of edible stimuli
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Galeazzi

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 (Anticipated)

February 1, 2020

Primary Completion (Anticipated)

February 1, 2021

Study Completion (Anticipated)

January 31, 2023

Study Registration Dates

First Submitted

December 16, 2019

First Submitted That Met QC Criteria

December 16, 2019

First Posted (Actual)

December 18, 2019

Study Record Updates

Last Update Posted (Actual)

December 18, 2019

Last Update Submitted That Met QC Criteria

December 16, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • FOOD

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.

Subscribe