Metabolic Diet for Relapse Prevention in Anorexia Nervosa

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT05197309
Status
Recruiting
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Conditions

  • Anorexia Nervosa

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Metabolic Diet — DIETARY_SUPPLEMENT
    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.

Study Details

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.

Key Dates

Start date
Nov 20, 2022
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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

Primary Outcome Measure

Number of adverse events [ Time Frame: 10 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Chinara Tate
[email protected]
212-659-8724
Tom Hildebrandt
[email protected]
212-659-8673
Chinara Tate (PRINCIPAL_INVESTIGATOR)

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