Actively Recruiting
Networks Integrating Anxiety and Metabolism in Human Anorexia Nervosa A Randomised Controlled Trial on Physiological and Psychological Responses to Caloric and Non-Caloric Meals
Led by Umeå University · Updated on 2025-05-08
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Umeå University
Lead Sponsor
E
Ege University Medical School
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying anorexia nervosa (AN), a serious psychiatric disorder with the highest mortality rate, focusing on how caloric and non-caloric food intake affects stress responses and brain activity. The study compares female AN patients aged 13 to 18 who are newly diagnosed and treatment-na ve, with healthy volunteers matched by age, sex, and education. The aim is to understand biological and psychological responses linked to eating in AN and to explore brain network changes related to calorie intake through neuroendocrine and psychological measures. Participants will be randomly assigned to consume one of two jellies: a 400-calorie mixture or a calorie-free mixture, both prepared to look and taste similar. AN patients will be admitted overnight to ensure a 12-hour fast before the study day. After psychiatric assessments and initial brain scans, participants will consume the jelly within 15 minutes, and their intake amount will be recorded. A second brain scan one hour later will assess brain network changes. Three hours later, participants will be offered a standard oatmeal meal with calories, allowed up to 500 kcal, and the amount consumed will also be measured. Throughout the study, participants will undergo psychiatric evaluations, blood sampling for hormones and biochemical markers, blood pressure and pulse monitoring, and brain MRI scans before and after meal intake. Self-report scales will assess hunger, anxiety, mood, and eating-related fears. Researchers will compare physiological, psychological, and behavioral responses before and after meals between AN patients who receive calories, those who do not, and matched healthy controls. The study will last until the end of 2026 with ongoing monitoring and data analysis.
CONDITIONS
Brief Title
A Randomised Controlled Trial on the Networks Integrating Anxiety and Metabolism in Anorexia Nervosa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female individuals
- Aged 13 to 18 years
- Currently patients at the eating disorder clinic
- Newly diagnosed with anorexia nervosa according to DSM-5
- Treatment na�ve (no previous treatment received)
- Healthy controls matched by age, sex, and education level with AN participants
- Diagnosis validated or ruled out by Structured Clinical Interview for DSM-5 (SCID-5)
You will not qualify if you...
- Chronic medical conditions interfering with participation or outcomes
- Use of medications affecting hormone levels or eating behavior
- Severe psychiatric disorders other than anorexia nervosa (e.g., schizophrenia, major depression, bipolar disorder)
- Current drug abuse, pregnancy, or potential pregnancy
- High risk of refeeding syndrome or severe complications related to eating disorders
- Inability to comply with the nutritional program
- Allergies to foods included in study meals
- Cognitive impairments preventing understanding of the study or consent process
- Contraindications for MRI (e.g., pacemaker, prosthesis, claustrophobia)
- Fasting blood glucose above 6.0 mmol/l on study morning
- For healthy controls: current or past eating disorders
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants are randomized to consume either a 400 kilocalorie meal or a calorie-free meal. They will be admitted overnight for a 12-hour fast before the intervention. Participants consume the assigned meal in the morning within 15 minutes, followed by a second calorie-containing meal three hours later. Food consumption amounts are recorded.
1 overnight admission plus 1 day with multiple assessments
Duration - Up to 3 hours post intervention
Participants undergo multiple assessments including magnetic resonance imaging, blood sampling, blood pressure and pulse measurements, and self-rated psychometrics at various timepoints up to three hours after the first meal.
1 day with assessments at 15 minutes, 1 hour, and 3 hours post meal
Trial Site Locations
Total: 1 location
1
Ege university hospital
Izmir, Turkey (Türkiye), 35100
Actively Recruiting
Research Team
O
Olof Lagerlöf
E
Erik Ekbäck
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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