Metabolic Diet for preventing relapse in anorexia nervosa
Metabolic Diet for Relapse Prevention in Anorexia Nervosa
NA · Icahn School of Medicine at Mount Sinai · NCT05197309
This study tests if a special diet can help women who have recovered from anorexia nervosa stay healthy and prevent relapse.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Icahn School of Medicine at Mount Sinai (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05197309 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult women aged 18 to 40 who have been weight-restored from anorexia nervosa within the past 6 months.
Not a fit: Patients with current or lifetime diagnoses of other eating disorders or significant medical conditions may not benefit from this study.
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 performed: While similar dietary interventions have been explored, this specific approach focusing on metabolic stabilization in anorexia nervosa is relatively novel.
Eligibility criteria
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 this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Chinara Tate — Icahn School of Medicine at Mount Sinai
- Study coordinator: Chinara Tate
- Email: chinara.tate@mssm.edu
- Phone: (212) 659-8724
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anorexia Nervosa, anorexia nervosa, metabolic diet, weight-restored, eating disorders