Examining the effects of food intake on brain activity in anorexia nervosa
Networks Integrating Anxiety and Metabolism in Human Anorexia Nervosa, A Randomised Controlled Trial on Physiological and Psychological Responses to Caloric and Non-Caloric Meals
This study is testing how eating different types of food affects brain activity and stress responses in young women with anorexia nervosa compared to healthy volunteers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | Female |
| Sponsor | Umeå University Academic / other |
| Locations | 1 site (Izmir) |
| Trial ID | NCT06814002 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are female individuals aged 13-18 who are newly diagnosed with anorexia nervosa and treatment-naïve.
Not a fit: Patients with chronic medical conditions, severe psychiatric disorders other than AN, or those currently using medications affecting hormone levels or eating behaviors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment strategies for anorexia nervosa.
How similar studies have performed: While there is ongoing research in this area, this specific approach combining caloric intake and brain imaging in newly diagnosed AN patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Izmir
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.