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

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.

Study Overview

• Status: Unknown
• Conditions: Appetite Regulation
• Intervention / Treatment: Radiation: Fallypride

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospitals Leuven, Campus Gasthuisberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Healthy females.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy volunteers	Radiation: Fallypride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Lukas Van Oudenhove, MD, PhD, University Hospitals Leuven, Campus Gasthuisberg

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: November 19, 2014
• First Submitted That Met QC Criteria: December 3, 2014
• First Posted (Estimate): December 8, 2014

Study Record Updates

• Last Update Posted (Estimate): October 27, 2016
• Last Update Submitted That Met QC Criteria: October 25, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Fallypride
• Other Study ID Numbers: S56186