Striatal and Extra-striatal Dopamine Release in Response to Food in Healthy Humans

Appetite Regulation Clinical Trial

— DA-Fallypride  

Official title:

Measuring Food-induced Striatal and Extra-striatal Dopamine Release Using (18F)Fallypride Positron Emission Tomography

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02310360
• Other study ID #: S56186
• Status: Active, not recruiting
• Phase: N/A
• First received: November 19, 2014
• Last updated: October 25, 2016
• Start date: November 2014
• Est. completion date: March 2017

Study information

• Verified date: October 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: March 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Appetite Regulation

Intervention

Radiation:
• Fallypride

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven, campus Gasthuisberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year	No