NCT05197309 · Icahn School of Medicine at Mount Sinai
Metabolic Diet for Relapse Prevention in Anorexia Nervosa
What this study is about
This is an interventional study that will test the safety, tolerability, and effectiveness 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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Number of adverse events
Time frame: 10 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 food
Time frame: 10 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 logs
Time frame: Baseline 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations