A Randomised Controlled Trial on the Networks Integrating Anxiety and Metabolism in Anorexia Nervosa

Launched by UMEÅ UNIVERSITY · Feb 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how different types of food—caloric and non-caloric—affect stress responses and brain activity in young women with anorexia nervosa (AN) compared to healthy volunteers. The goal is to understand how eating affects their feelings and brain function, which could help develop better treatments for AN. The study will involve 30 newly diagnosed female patients aged 13-18 who have not received any treatment yet, alongside 30 healthy peers matched by age and education.

Participants will stay in a clinic overnight and fast for 12 hours before the study. They will complete some assessments and undergo brain scans before and after eating a jelly that is either 400 calories or calorie-free, without knowing which one they are consuming. Blood samples will also be taken to measure hormonal responses related to hunger and stress. The trial aims to gather insights into the psychological and physiological effects of food intake in AN patients, which might reveal important information for better understanding and treating the disorder.

Gender

FEMALE

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.