Metabolic Diet for Relapse Prevention in Anorexia Nervosa

N/ARecruitingNCT05197309

Icahn School of Medicine at Mount Sinai20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline to 10 weeks

Secondary Outcomes

Change in Weight

Weight will be calculated using the baseline weight and weight at the 10 week assessment. Weight will be during each of the 8 weekly clinician visits.