NCT05197309 Metabolic Diet for Relapse Prevention in Anorexia Nervosa
| NCT ID | NCT05197309 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Anorexia Nervosa |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-11-20 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2022-11-20 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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)
Contact & Investigator
Chinara Tate
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT05197309 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Anorexia Nervosa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05197309 currently recruiting?
Yes, NCT05197309 is actively recruiting participants. Contact the research team at chinara.tate@mssm.edu for enrollment information.
Where is the NCT05197309 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05197309 clinical trial?
NCT05197309 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Chinara Tate at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 20 participants.