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New treatment option for Anorexia Nervosa
Official title Ketogenic Diet and Brain Response in Anorexia Nervosa
ClinicalTrials.gov ID: NCT06540703
What this study is testing
- What it's testing
- This is a longitudinal study with an open design in weight recovered anorexia nervosa (wrAN) individuals. Healthy controls (HC) will also be assessed.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.