Appetite RegulationDA-FallyprideNCT02310360
Striatal and Extra-striatal Dopamine Release in Response to Food in Healthy Humans
An observational study of Appetite Regulation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The purpose of this study is to investigate whether a combination of taste probes and food-related cues can induce dopamine release in striatal and extra-striatal brain regions in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Appetite Regulation
- What is being tested?
- Fallypride
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2014to Mar 2025
- Phase
- Observational
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy females.
Who may be able to join
- Female
- 20 ≤ BMI ≤ 25
- Right handed
- Stable body weight for at least 3 consecutive months at start of study and no history of behavioral, therapeutic or surgical treatment aiming at or leading to weight loss/gain
- Subject understands the study procedures and agrees to participate in the study by giving written informed consent
Who cannot join
- Medical (current or history):
- Abdominal/thoracic surgery except appendectomy
- Gastrointestinal, endocrine (especially diabetes), or neurological diseases
- Cardiovascular, respiratory, renal or urinary diseases
- Hypertension
- Food or drug allergies
Show all 27Show fewer
- Head trauma with loss of consciousness
- Psychiatric disorders (current or history):
- Eating disorders
- Psychotic disorders
- Major depressive disorder
- Somatoform disorder
- Emotional and/or restraint eating
- Treatment in the last 6 months with antidepressants (as MAO inhibitors), neuroleptics, sedative hypnotics, psychostimulants, glucocorticoids, appetite suppressants, estrogens, opiate, or dopamine medications. Oral contraception is allowed
- History of cannabis use or any other drug of abuse for at least 12 months prior to the study
- Intolerance of lactose
- Vegetarians
- Smoking and alcohol intake greater than 5 alcoholic units per week (one alcoholic unit = 10 gr ethanol)
- More than moderate exercise (> 30 min, five times per week of walking or equivalent)
- High caffeine intake (> 500 ml coffee daily or equivalent)
- Exposure to a significant amount (> 1mSv) of ionizing radiation in other research studies within the last 12 months
- Claustrophobia or too much uneasiness in limited spaces (in order tolerate confinement during PET scanning procedures)
- Inability or unwillingness to perform all of the study procedures, or if the subject is considered unsuitable in any way by the principal investigator
- Recent participation (< 30 days) or simultaneous participation in another clinical trial
- Any condition that would interfere with Magnetic Resonance Imaging (MRI) or PET studies (e.g., cochlear implant, metal fragments in eyes, cardiac pacemaker, neural stimulator, and metallic body inclusion or other metal implanted in the body which may interfere with MRI scanning)
- Anemia
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring Food-induced Striatal and Extra-striatal Dopamine Release Using (18F)Fallypride Positron Emission Tomography
The purpose of this study is to investigate whether a combination of taste probes and food-related cues can induce dopamine release in striatal and extra-striatal brain regions in healthy subjects.
- Conditions
- Appetite Regulation
- Being tested
- Fallypride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FallyprideRadiation
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Not described Receives: Radiation: Fallypride |
What is being measured
The primary outcome is the main question the study is designed to answer.
DA release in both striatal and extra-striatal brain regions
A [18F]Fallypride PET protocol and the linearized simplified reference region model (LSSRM) kinetic model will be used to detect DA release.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetite RegulationStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lukas Van Oudenhove, MD, PhD, Principal investigator, University Hospitals Leuven, campus Gasthuisberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310360
- Sponsor's protocol ID
- S56186
- Acronym
- DA-Fallypride
- Status last verified
- Jul 2024
- First submitted
- 19 Nov 2014
- Last updated
- 10 Jul 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Food-induced Striatal and Extra-striatal Dopamine Release Using (18F)Fallypride Positron Emission Tomography
- ClinicalTrials.gov ID
- NCT02310360
- Acronym / sponsor ID
- DA-Fallypride / S56186
- Conditions
- Appetite Regulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2025 (estimated)
- First posted
- 8 Dec 2014 (estimated)
- 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.
The purpose of this study is to investigate whether a combination of taste probes and food-related cues can induce dopamine release in striatal and extra-striatal brain regions in healthy subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Radiation: Fallypride |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy females.
Key inclusion criteria (5 listed)
- Female
- 20 ≤ BMI ≤ 25
- Right handed
- Stable body weight for at least 3 consecutive months at start of study and no history of behavioral, therapeutic or surgical treatment aiming at or leading to weight loss/gain
- Subject understands the study procedures and agrees to participate in the study by giving written informed consent
Key exclusion criteria (27 listed)
- Medical (current or history):
- Psychiatric disorders (current or history):
- History of cannabis use or any other drug of abuse for at least 12 months prior to the study
- Intolerance of lactose
- Vegetarians
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 |
|---|---|---|
| Fallypride | Radiation | Healthy volunteers |
Primary outcome
DA release in both striatal and extra-striatal brain regions
Time frame: 1 year
A [18F]Fallypride PET protocol and the linearized simplified reference region model (LSSRM) kinetic model will be used to detect DA release.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
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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.
Lukas Van Oudenhove, MD, PhD principal investigator
University Hospitals Leuven, campus Gasthuisberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appetite Regulation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 5 inclusion and 27 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 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
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?
DA release in both striatal and extra-striatal brain regions (time frame: 1 year). 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 Jul 2024.