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Striatal and Extra-striatal Dopamine Release in Response to Food in Healthy Humans (DA-Fallypride)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02310360
Recruitment Status : Unknown
Verified October 2016 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Active, not recruiting
First Posted : December 8, 2014
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief 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.

Condition or disease Intervention/treatment
Appetite Regulation Radiation: Fallypride

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Measuring Food-induced Striatal and Extra-striatal Dopamine Release Using (18F)Fallypride Positron Emission Tomography
Study Start Date : November 2014
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : March 2017

Group/Cohort Intervention/treatment
Healthy volunteers Radiation: Fallypride



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy females.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310360


Locations
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Belgium
University Hospitals Leuven, campus Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Lukas Van Oudenhove, MD, PhD University Hospitals Leuven, campus Gasthuisberg
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02310360    
Other Study ID Numbers: S56186
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Fallypride
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs