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

NCT02310360 | Active Not Recruiting

• 1 other identifier: S56186
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Appetite Regulation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Healthy volunteers

Radiation: Fallypride

Interventions

Fallypride RADIATION

Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy females.

You may qualify if:

• Female
• ≤ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven, campus Gasthuisberg

Leuven, 3000, Belgium

Location

MeSH Terms

Interventions

fallypride

Study Officials

• Lukas Van Oudenhove, MD, PhD

  University Hospitals Leuven, campus Gasthuisberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: December 8, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2025
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

BE (1)