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NCT Number: NCT02310360

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

University Hospitals Leuven, campus Gasthuisberg

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fallypride

Radiation

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: DA-Fallypride

Important dates

Study start
2014
Primary completion
2015
Study completion
2025
First posted
Dec 8, 2014
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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