Metabolic Diet for Relapse Prevention in Anorexia Nervosa

NCT ID: NCT05197309

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-20
• Study Completion Date: 2026-12-31

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.

Detailed Description

The study plan to enroll a total of 20 subjects from the broader New York City area into an 8-week eating behavioral program. Of the 20, 10 will be weight-restored patients with anorexia nervosa (WR-AN) and the other 10 will be age-, sex-, and body mass index (i.e. weight) matched healthy controls (HC).

The primary study intervention is an eating behavioral program called, Metabolic Diet, which is aimed to change the proportion of macronutrients in their meals to incorporate higher fat content and lower the carbohydrate content to limit fluctuations in circulating blood glucose levels throughout the day, which may contribute to a relapse in anorexia nervosa. Participants will be guided to start the Metabolic Diet following the first 2 individual study visits, and the duration of the primary intervention is for 8 weeks. As part of the intervention, each subject will keep a food log and measure the urinary ketones at home, which they will discuss with the study providers during weekly visits. Each subject will meet individually with the Study Dietician and with the Study Physician on a weekly basis. At these visits, food logs and ketone logs will be reviewed so that subjects' adherence to the Metabolic Diet can be assessed and facilitated.

Surveys and lab work are completed during screening, week 4 and week 8.

Conditions

Anorexia Nervosa

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Women with anorexia nervosa

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

Group Type: ACTIVE_COMPARATOR

Metabolic Diet

Intervention Type: 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 no history of eating disorders

adult women with no history of eating disorders

Group Type: ACTIVE_COMPARATOR

Metabolic Diet

Intervention Type: 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.

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Chinara Tate

Clinical Nutrition Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chinara Tate

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chinara Tate

Role: CONTACT

chinara.tate@mssm.edu

(212) 659-8724

Tom Hildebrandt

Role: CONTACT

tom.hildebrandt@mssm.edu

212-659-8673

Facility Contacts

Chinara Tate

Role: primary

chinara.tate@mssm.edu

212-659-8724

Tom Hildebrandt

Role: backup

tom.hildebrandt@mssm.edu

212-659-8673

Other Identifiers

STUDY-20-01956

Identifier Type: -

Identifier Source: org_study_id