Examining the effects of food intake on brain activity in anorexia nervosa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates how caloric and non-caloric food intake affects stress responses and brain network activity in patients with anorexia nervosa (AN) and healthy volunteers. The study includes 30 newly diagnosed female AN patients aged 13-18 and 30 matched healthy controls. Participants will undergo a 12-hour fasting period before being randomized into two groups: one receiving a meal with calories and the other receiving a meal without calories. The primary outcome is brain patterns observed through MRI, while secondary outcomes include endocrine markers, cardiovascular responses, and self-reported symptom severity.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ege university hospital
  Izmir, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Olof Lagerlöf, MD, PhD — Umea University
• Study coordinator: Olof Lagerlöf
• Email: olof.lagerlof@umu.se
• Phone: +46 90-785 00 00

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.