Food Oriented BehaviorNCT04203706
Behavioral and Neurofunctional Correlates of Intentional Motor Behaviors Towards Edible Stimuli in Normal-weight Subjects
A study testing Neurofunctional imaging in people with Food Oriented Behavior, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Oriented Behavior
- What is being tested?
- Neurofunctional imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
- Conditions
- Food Oriented Behavior
- Being tested
- Neurofunctional imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofunctional imagingOther
Subjects will be submitted to a functional neuroimaging scanning procedure
| Study group | Role | What they receive |
|---|---|---|
| Normal-weight subjects | Experimental | Not described Receives: Other: Neurofunctional imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD Response
We will record the BOLD response during the visualization of edible stimuli
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start1 Feb 2020 (estimated)
- Primary completion1 Feb 2021 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Oriented BehaviorStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203706
- Sponsor's protocol ID
- FOOD
- Status last verified
- Dec 2019
- First submitted
- 16 Dec 2019
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral and Neurofunctional Correlates of Intentional Motor Behaviors Towards Edible Stimuli in Normal-weight Subjects
- ClinicalTrials.gov ID
- NCT04203706
- Acronym / sponsor ID
- FOOD
- Conditions
- Food Oriented Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal-weight subjects | Experimental | Other: Neurofunctional imaging |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurofunctional imagingSubjects will be submitted to a functional neuroimaging scanning procedure | Other | Normal-weight subjects |
Primary outcome
BOLD Response
Time frame: 3 years
We will record the BOLD response during the visualization of edible stimuli
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Food Oriented Behavior
Not yet recruiting
Pilot Study of Capacity-oriented Intervention to Promote Food Security and Diet Quality Among Hispanics/Latinos
Nutrition, Healthy, Knowledge, Attitudes, Practice
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofunctional imaging in people with Food Oriented Behavior, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD Response (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019.