Metabolic Diet for Relapse Prevention in Anorexia Nervosa

This study is testing a "Metabolic Diet" to see if it can help women with anorexia nervosa stay at a healthy weight after they've recovered from being underweight. The diet involves eating more foods high in fat and fewer foods that cause big changes in blood sugar. Researchers want to see if this diet is safe, if people can stick to it, and if it helps prevent relapse. You might be able to join if you are a woman between 18 and 40, speak English, are medically stable, and have a history of anorexia nervosa but are now at a healthy weight (BMI at or above 18.5 kg/m2). The study will look at how many side effects occur, and how well participants complete food and ketone logs over 10 weeks. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 20 participants: 10 women who have recovered from anorexia nervosa and 10 healthy women. It is not specified if this is a randomized or blinded study.
What's involved
You would meet weekly with a registered dietitian and study physician for 8 weeks. You would also keep food logs and measure urinary ketones at home, discussing these during your weekly visits. Surveys and lab work are completed at screening, week 4, and week 8.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at 10 weeks, suggesting follow-up for at least that duration.

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NCT05197309

Metabolic Diet for Relapse Prevention in Anorexia Nervosa

Recruiting
NAAges 18–40InterventionalPrevention
Icahn School of Medicine at Mount Sinai
~20 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:Metabolic Diet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of adverse events
Measured over 10 weeks
+2 more outcomes measured
Anorexia Nervosa
1 sites across 1 states
New York1
  • Chinara Tate · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

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Eligibility criteria

Inclusion

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

Current/lifetime diagnosis of DSM-5 psychotic disorders, bipolar disorders
Active DSM-5 substance use disorders
On medications that could affect metabolism
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)
  • Number of adverse events10 weeks

    Safety of intervention will be measured by # of adverse events reported over 10 weeks. Adverse events will be documented during each of the 8 weekly clinician visits.

  • Percent completion of food10 weeks

    Tolerability of intervention will be measured using percent completion of food over 10 weeks. Logs are collected during each of the 8 weekly clinician visits.

  • Percent completion of ketone logsBaseline to 10 weeks

    Tolerability of intervention will be measured using percent completion of ketone logs over 10 weeks. Logs are collected during each of the 8 weekly clinician visits.