- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05357053
Anorexia Nervosa and Its Effects on Brain Function, Body Metabolism and Their Interaction in Adolescents (AVAIN_JR)
September 16, 2025 updated by: Turku University Hospital
The aim of the research project is to investigate the neurological, physiological and behavioral underpinnings associated with the development of anorexia nervosa in adolescents.
The goal of the project is to enable new ways to both predict the course of the disease and to influence this process.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
The aim of the project is to enable new ways to both predict and influence the course of anorexia nervosa.
This is a three-year follow-up study in which we investigate the neurological and physiological factors underpinnings of anorexia nervosa with structural and functional magnetic resonance imaging (fMRI).
In addition to this, a variety of methods is used, such as physiological measurements and questionnaire data, as well as investigation of intestinal microbiota associated with anorexia nervosa.
Altogether 100 girls aged 13-17 will be recruited for the study: 50 patients with anorexia nervosa and 50 healthy controls.
The participants are monitored annually and the fMRI scan is repeated at the last visit.
Additionally, 40 participants (20 patients and 20 healthy controls) will participate in a cardiac sub-study.
In this, the participants will also have an MRI scan and ultrasound examination of the heart.
Study Type
Observational
Enrollment (Actual)
33
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Turku, Finland, 20521
- Turku PET Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 17 years (Child)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
The study population comprises 50 female adolescents with anorexia nervosa meeting the inclusion criteria.
They are compared with 50 age and sex-matched healthy normal weight controls.
Description
Inclusion criteria for anorexia nervosa patients:
- Female sex
- Age 13-17 years
- Body mass index < 17.5 kg/m2
- Currently fulfilling modified Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis criteria for anorexia nervosa with or without amenorrhea
- Anorexia nervosa diagnosed within 2 yers
Inclusion criteria for healthy controls:
- Female sex
- Age 13-17 years
- Body mass index 18,5-25 kg/m2
- No lifetime history of obesity (Body mass index ≥ 30) or eating disorders
Exclusion criteria:
- Any chronic illness or medication that could affect glucose metabolism or neurotransmission
- Any other current mental disorder (excluding anorexia nervosa for the patient participants)
- Severe previous mental disorder (excluding anorexia nervosa for the patient participants)
- Smoking of tobacco, snuffing, or use of narcotics
- Abusive use of alcohol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Anorexia nervosa patients
|
|
Healthy normal weight controls
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in brain reward system and metabolism in anorexia nervosa patients
Time Frame: 3 years
|
Anorexia nervosa patients and controls are studied using fMRI imaging and followed up for 3 years.
Reward system function is measured using fMRI and metabolism using blood oxygen level-dependent (BOLD) echo-planar imaging.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Max Karukivi, MD, PhD, Turku University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Actual)
December 31, 2024
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
March 28, 2022
First Submitted That Met QC Criteria
April 26, 2022
First Posted (Actual)
May 2, 2022
Study Record Updates
Last Update Posted (Actual)
September 22, 2025
Last Update Submitted That Met QC Criteria
September 16, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- T163_2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.