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RECRUITINGINTERVENTIONAL

Metabolic Diet for Relapse Prevention in Anorexia Nervosa

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is an interventional study that will test the safety, tolerability, and efficacy of the Metabolic Diet, which was designed as a treatment for women with anorexia nervosa to remain weight-stable after they have been restored from low weight. Participants will be adult women with anorexia nervosa who have been recently restored to normal weight and adult women with no history of eating disorders. After enrollment, participants will start meeting weekly with a registered dietitian to implement the Metabolic Diet in their daily lives, and will receive medical monitoring for adherence, side effects, changes in metabolic or psychological parameters, and weight stability.

Who May Be Eligible (Plain English)

Who May Qualify: - Female - Age at least 18 and not over 40 - BMI at or above 18.5 kg/m2 - Speaks English - Medically stable, as cleared by a licensed physician, with vital signs and initial blood draws - History of DSM-5 diagnosis of Anorexia Nervosa (WR-AN only) - Weight-restored from underweight BMI (under 18.5 kg/m2) within the past 6 months (WR-AN only) Who Should NOT Join This Trial: - Current/lifetime diagnosis of DSM-5 psychotic disorders, bipolar disorders - Active DSM-5 substance use disorders - On medications that could affect metabolism \*Subjects are to be free of any medications that could affect metabolism, as discussed with study physician, for 2 weeks prior to primary study visit for glucose function testing. - History of suicide attempt within previous 6 months or acute suicide risk - Significant current medical illness or metabolic conditions, including diabetes mellitus and pregnancy - Current/lifetime diagnosis of DSM-5 eating disorders (HC only) - Active DSM-5 depressive disorders (HC only) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Female * Age at least 18 and not over 40 * BMI at or above 18.5 kg/m2 * Speaks English * Medically stable, as cleared by a licensed physician, with vital signs and initial blood draws * History of DSM-5 diagnosis of Anorexia Nervosa (WR-AN only) * Weight-restored from underweight BMI (under 18.5 kg/m2) within the past 6 months (WR-AN only) Exclusion Criteria: * Current/lifetime diagnosis of DSM-5 psychotic disorders, bipolar disorders * Active DSM-5 substance use disorders * On medications that could affect metabolism \*Subjects are to be free of any medications that could affect metabolism, as discussed with study physician, for 2 weeks prior to primary study visit for glucose function testing. * History of suicide attempt within previous 6 months or acute suicide risk * Significant current medical illness or metabolic conditions, including diabetes mellitus and pregnancy * Current/lifetime diagnosis of DSM-5 eating disorders (HC only) * Active DSM-5 depressive disorders (HC only)

Treatments Being Tested

DIETARY_SUPPLEMENT

Metabolic Diet

Metabolic Diet includes increasing the amount of foods high in fat and decreasing the amount of foods that may cause increased flux in blood glucose levels. Food logs and ketone logs will be reviewed weekly during the 8 weeks of the intervention.

Locations (1)

Icahn School of Medicine at Mount Sinai
New York, New York, United States