RecruitingNot ApplicableNCT05197309

Metabolic Diet for Relapse Prevention in Anorexia Nervosa

Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

20 participants

Start Date

Nov 20, 2022

Study Type

INTERVENTIONAL

Conditions

Anorexia Nervosa

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria7

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 Criteria8

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)

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Interventions

DIETARY_SUPPLEMENTMetabolic 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.