Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT06814002
Eligibility Criteria:
Inclusion criteria:
* Female individuals
* 13-18 years of age
* Currently patients at the eating disorder clinic
* Newly diagnosed with AN according to the Diagnostic and Statistical Manual of mental disorders 5th edition (DSM-5)
* Treatment naïve
Healthy control participants will be matched on age-, sex-, and education level with the AN-participants. The clinical diagnosis/diagnoses for participants will be validated/ruled out by the Structured Clinical Interview for DSM-5 (SCID-5). The presence of other exclusion criteria will also be further explored at the clinical visit.
Exclusion criteria:
* Having one or several chronic medical conditions that may interfere with or hinder participation, or affect study outcomes.
* Use of medications that affect hormone levels or eating behaviors.
* Having one or several severe psychiatric disorders other than AN (e.g., schizophrenia, major depressive disorder, bipolar disorder).
* Current drug abuse, pregnancy or potential pregnancy (for AN patients these conditions are excluded as a part of routine care. For healthy controls no objective testing will be performed).
* High risk of refeeding syndrome or severe complications related to eating disorders.
* Inability to comply with the nutritional program of the study.
* Allergies to foods included in the provided meal content.
* Cognitive impairments preventing comprehension of the study or the informed consent process.
* Contraindications for MRI (e.g., pacemaker, prosthesis, claustrophobia), and
* Fasting blood glucose above 6.0 mmol/l on the morning of the study, as this indicates either non compliance with overnight fasting or pre-diabetes/diabetes..
Additional exclusion criterion for healthy controls: (1.) Having one or several eating disorders, current or past.
Participant inclusion in the study will be determined by a study clinician based on the outlined eligibility criteria. In cases of uncertainty, the principal investigator will make the final decision. Importantly, to maintain impartiality and avoid selective recruitment bias, enrolling clinicians will be masked to future treatment allocations, as randomization will occur at a later point in time.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
13 Years
Maximum Age:
18 Years
Study:
NCT06814002
Study Brief:
Protocol Section:
NCT06814002