Ketogenic diet's effects on brain response in individuals recovered from anorexia nervosa
Ketogenic Diet in Weight Recovered Anorexia Nervosa to Normalize Brain Metabolism and Persistent Eating Disorder Psychopathology
This study is testing if a special ketogenic diet can change how the brains of people who have recovered from anorexia nervosa work, compared to healthy individuals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT06540703 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of a therapeutic ketogenic diet (TKD) on individuals who have recovered from anorexia nervosa (wrAN) by comparing their brain glucose metabolism to that of healthy controls. Participants will undergo 18F-fluorodeoxyglucose (FDG) PET scans before and after a 14-week TKD intervention to assess changes in brain function. The study aims to establish metabolic markers related to anorexia nervosa and evaluate the safety and tolerability of the diet. Follow-up assessments will occur over six months to determine the stability of symptom improvement post-intervention.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18-45 who have recovered from restricting-type anorexia nervosa with a BMI greater than 17.5.
Not a fit: Patients currently pregnant, nursing, or with a history of severe psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary intervention that improves brain function and reduces symptoms in individuals with a history of anorexia nervosa.
How similar studies have performed: While some small studies have suggested that ketosis may be beneficial for anorexia nervosa, this approach is still relatively novel and untested on a larger scale.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Weight Recovered Anorexia Nervosa (wrAN) * Age 18-45 years old * Male and Female sexes * All ethnic backgrounds * History of restricting-type anorexia nervosa (AN) according to DSM-5 criteria * Weight recovered with a body mass index \> 17.5 for at least one month at the time of study * Elevated eating disorder-relevant behaviors on the Eating Disorders Inventory-3 and the Eating Disorder Examination Questionnaire Healthy Control Group * Age 18-45 years old * Male and Female sexes * All ethnic backgrounds * Normal lifetime BMI according to CDC Exclusion Criteria: Weight Recovered Anorexia Nervosa (AN) * Current pregnancy or nursing (will have to agree to contraceptive measures if sexually active) * Lifetime history of bipolar I disorder or psychosis * Current substance abuse or dependence in the past 3 months * Psychotic illness/other organic brain syndromes, dementia, somatization disorders or conversion disorders * History of significant head trauma * Indication of intellectual disability or autism spectrum disorder Healthy Control Group * No lifetime psychiatric illness and in particular no eating disorder history * Not be taking medication, and will not have a first degree relative with an eating disorder. No subject in either group will have or be * mental retardation or pervasive developmental disorder * organic brain syndrome * dementia * psychotic disorder * bipolar disorder * somatic symptom * conversion disorder * current alcohol or substance use disorder * indication of major medical illness including a history of seizure disorder * pregnant or nursing at the time of the study * a history of traumatic brain injury. * diabetes mellitus or other metabolic disorders that could worsen on a ketogenic diet * intracranial or any other metal object within or near the head that cannot be safely removed, excluding the mouth * implanted neurostimulators, intracardiac lines, or heart disease
Where this trial is running
San Diego, California
- University of California San Diego — San Diego, California, United States (Recruiting)
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.