Metabolic Diet for Relapse Prevention in Anorexia Nervosa

NCT05197309 | Recruiting

• 1 other identifier: STUDY-20-01956
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Number of adverse events

  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.

  10 weeks

• Percent completion of food

  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.

  10 weeks

• Percent completion of ketone logs

  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.

  Baseline to 10 weeks

Secondary Outcomes (27)

• Change in Weight

  Baseline and 10 weeks

• Change in Eating Disorder Examination Questionnaire (EDE-Q)

  Baseline and 10 weeks

• Changes in Anxiety using the Beck Anxiety Inventory (BAI)

  Baseline and 10 weeks

• Changes in Mood using the Quick Inventory of Depressive Symptomatology (QIDS)

  Baseline and 10 weeks

• Changes in Clinical Impairments using the Clinical Impairment Assessment (CIA)

  Baseline and 10 weeks

Study Arms (2)

Women with anorexia nervosa

ACTIVE COMPARATOR

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

Dietary Supplement: Metabolic Diet

Women with no history of eating disorders

ACTIVE COMPARATOR

adult women with no history of eating disorders

Dietary Supplement: Metabolic Diet

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.

Women with anorexia nervosa; Women with no history of eating disorders

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chinara Tate

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chinara Tate

CONTACT

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

Tom Hildebrandt

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nutrition Coordinator

Model Details: All participants will complete 8 weeks of the Metabolic Diet while meeting with a clinician weekly.

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 19, 2022
• Study Start: November 20, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)