Food PreferencesNCT04662606
Neurofunctional Correlates of Intentional Actions Towards Food Stimuli
A study testing Consumption of a standard meal prior to the fMRI data collection in people with Food Preferences, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 2 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Preferences
- What is being tested?
- Consumption of a standard meal prior to the fMRI data collection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesItaly
- Study dates
- 12 Sep 2020to 1 Dec 2022
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal weight (normal BMI)
- No MRI controindications
- No neurological or cognitive problems
Who cannot join
- Underweight or overweight
- MRI controindications
- Neurological or cognitive problems
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Galeazzi
Milan, Italia, 20161
Laura Zapparoli, PhD, 02 6621 4444, laura.zapparoli@gmail.com
Laura Zapparoli, PhD
- Recruiting
IRCCS Istituto Ortopedico Galeazzi
Milan, Milano, 20126
Laura Zapparoli, PhD, 390264483776, laura.zapparoli@unimib.it
About this study
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.
- Conditions
- Food Preferences
- Being tested
- Consumption of a standard meal prior to the fMRI data collection
- Medical subject headings
- Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consumption of a standard meal prior to the fMRI data collectionBehavioural
Consumption of a standard meal prior to the fMRI data collection
| Study group | Role | What they receive |
|---|---|---|
| Fasting-group | No intervention | Not described |
| Fed-group | Experimental | Not described Receives: Behavioral: Consumption of a standard meal prior to the fMRI data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: This outcome will be measured on the recruitment day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start12 Sep 2020
- Primary completion12 Sep 2021 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food PreferencesStudies 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
- Randomised
- Intervention model
- Parallel groups
- 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
- NCT04662606
- Sponsor's protocol ID
- CONSUME
- Status last verified
- Dec 2020
- First submitted
- 3 Dec 2020
- Last updated
- 10 Dec 2020
- Results posted
- No
- 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 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofunctional Correlates of Intentional Actions Towards Food Stimuli
- ClinicalTrials.gov ID
- NCT04662606
- Acronym / sponsor ID
- CONSUME
- Conditions
- Food Preferences
- 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
- 12 Sep 2020 (actual)
- Primary completion
- 12 Sep 2021 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 10 Dec 2020 (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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting-group | No intervention | – |
| Fed-group | Experimental | Behavioral: Consumption of a standard meal prior to the fMRI data collection |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Normal weight (normal BMI)
- No MRI controindications
- No neurological or cognitive problems
Key exclusion criteria (3 listed)
- Underweight or overweight
- MRI controindications
- Neurological or cognitive problems
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 |
|---|---|---|
| Consumption of a standard meal prior to the fMRI data collectionConsumption of a standard meal prior to the fMRI data collection | Behavioural | Fed-group |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consumption of a standard meal prior to the fMRI data collection in people with Food Preferences, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 2 sites in Italy.
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 3 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 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD (Blood Oxygen Level Dependent) signal (time frame: This outcome will be measured on the recruitment day). 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 10 Dec 2020.