Clinical trial Recruiting at 1 site Interventional Ages 18 to 40 Women only

Metabolic Diet for preventing relapse in anorexia nervosa

Official title: Metabolic Diet for Relapse Prevention in Anorexia Nervosa

Run by Icahn School of Medicine at Mount Sinai · NCT05197309 · Data updated 2026-11-12

This study tests if a special diet can help women who have recovered from anorexia nervosa stay healthy and prevent relapse.

Quick facts

Study typeInterventional
Ages18 Years to 40 Years
SexWomen only
Enrollment20 (estimated)
SponsorIcahn School of Medicine at Mount Sinai
Academic / other
Locations1 site (New York, New York)
StatusRecruiting
StartedNovember 20, 2022
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedFebruary 27, 2026
Trial IDNCT05197309 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adult women aged 18 to 40 who have been weight-restored from anorexia nervosa within the past 6 months.

Probably not a fit

Patients with current or lifetime diagnoses of other eating disorders or significant medical conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates the safety, tolerability, and efficacy of a Metabolic Diet designed for women with anorexia nervosa who have recently achieved a healthy weight. The study will enroll 20 participants, including 10 weight-restored women with anorexia nervosa and 10 matched healthy controls. Participants will meet weekly with a registered dietitian to implement the diet, which focuses on altering macronutrient proportions to stabilize blood glucose levels. The intervention lasts for 8 weeks, during which adherence and metabolic parameters will be monitored.

Why it matters

Potential benefit: If successful, this approach could help women with anorexia nervosa maintain weight stability and reduce the risk of relapse.

How similar studies have gone: While similar dietary interventions have been explored, this specific approach focusing on metabolic stabilization in anorexia nervosa is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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)

Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.