Recruiting

Metabolic Diet

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05197309

Conditions

Anorexia Nervosa

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Metabolic Diet

Study Details

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.

Conditions

Anorexia Nervosa

Study ID

NCT05197309

Start date

Nov 20, 2022

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Women with anorexia nervosa

adult women with anorexia nervosa who have been recently restored to normal weight

active comparator: Women with no history of eating disorders

adult women with no history of eating disorders

Interventions

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 measure

  • Number of adverse events [ Time Frame: 10 weeks ]
  • Percent completion of food [ Time Frame: 10 weeks ]
  • Percent completion of ketone logs [ Time Frame: Baseline to 10 weeks ]

Central Contacts and Locations

Central contacts

Chinara Tate

(212) 659-8724chinara.tate@mssm.edu

Tom Hildebrandt

212-659-8673tom.hildebrandt@mssm.edu

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Chinara Tate

212-659-8724chinara.tate@mssm.edu

Tom Hildebrandt

212-659-8673tom.hildebrandt@mssm.edu

Principal Investigator:

Chinara Tate

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • anorexia nervosa
  • metabolic diet
  • weight-restored
  • eating disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-02-27.