Anorexia NervosaAVAIN_JRNCT05357053
Anorexia Nervosa and Its Effects on Brain Function, Body Metabolism and Their Interaction in Adolescents
An observational study of Anorexia Nervosa, run by Turku University Hospital at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 17 years, women only
- Conditions the study is for
- Anorexia Nervosa
- How many people
- 33 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2022to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- Women only
- Child
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.
Who may be able to join
- 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
- Female sex
Show all 9Show fewer
- Age 13-17 years
- Body mass index 18,5-25 kg/m2
- No lifetime history of obesity (Body mass index ≥ 30) or eating disorders
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia nervosa, Metabolism, Functional Imaging, Eating disorders
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anorexia nervosa patients | Anorexia nervosa patients | |
| Healthy normal weight controls | Healthy normal weight controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in brain reward system and metabolism in anorexia nervosa patients
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Turku
- Responsible party
- Sponsor
- Investigators
- Max Karukivi, MD, PhD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357053
- Sponsor's protocol ID
- T163_2021
- Acronym
- AVAIN_JR
- Status last verified
- Apr 2025
- First submitted
- 28 Mar 2022
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anorexia Nervosa and Its Effects on Brain Function, Body Metabolism and Their Interaction in Adolescents
- ClinicalTrials.gov ID
- NCT05357053
- Acronym / sponsor ID
- AVAIN_JR / T163_2021
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia nervosa, Metabolism, Functional Imaging, Eating disorders
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- University of Turku
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anorexia nervosa patients | – | –Anorexia nervosa patients |
| Healthy normal weight controls | – | –Healthy normal weight controls |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- Female only
- Age groups
- Child
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Max Karukivi, MD, PhD principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in brain reward system and metabolism in anorexia nervosa patients (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.