Clinical trial NCT05197309: Metabolic Diet for Relapse Prevention in Anorexia Nervosa
Official title: Metabolic Diet for Relapse Prevention in Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Keywords: anorexia nervosa
metabolic diet
weight-restored
eating disorders
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants will complete 8 weeks of the Metabolic Diet while meeting with a clinician weekly.
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Number of adverse events
timeFrame: 10 weeks
measure: Percent completion of food
timeFrame: 10 weeks
measure: Percent completion of ketone logs
timeFrame: Baseline to 10 weeks
Secondary outcomes:
measure: Change in Weight
timeFrame: Baseline and 10 weeks
measure: Change in Eating Disorder Examination Questionnaire (EDE-Q)
timeFrame: Baseline and 10 weeks
measure: Changes in Anxiety using the Beck Anxiety Inventory (BAI)
timeFrame: Baseline and 10 weeks
measure: Changes in Mood using the Quick Inventory of Depressive Symptomatology (QIDS)
timeFrame: Baseline and 10 weeks
measure: Changes in Clinical Impairments using the Clinical Impairment Assessment (CIA)
timeFrame: Baseline and 10 weeks
measure: Changes in Quality of Life using the Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) from Baseline to 10 Weeks
timeFrame: Baseline and 10 weeks
measure: Changes in Carbon Dioxide (CO2)
timeFrame: Baseline and 10 weeks
measure: Changes in Potassium level
timeFrame: Baseline and 10 weeks
measure: Changes in Sodium level
timeFrame: Baseline and 10 weeks
measure: Changes in Chloride
timeFrame: Baseline and 10 weeks
measure: Changes in Calcium
timeFrame: Baseline and 10 weeks
measure: Changes in Creatine
timeFrame: Baseline and 10 weeks
measure: Changes in Blood Urea Nitrogen (BUN)
timeFrame: Baseline and 10 weeks
measure: Changes in White Blood Count (WBC)
timeFrame: Baseline and 10 weeks
measure: Changes in Red Blood Count (RBC)
timeFrame: Baseline and 10 weeks
measure: Changes in Hemoglobin
timeFrame: Baseline and 10 weeks
measure: Changes in Hematocrit
timeFrame: Baseline and 10 weeks
measure: Changes in Platelet
timeFrame: Baseline and 10 weeks
measure: Changes in hemoglobin A1c
timeFrame: Baseline and 10 weeks
measure: Changes in Glucose
timeFrame: Baseline and 10 weeks
measure: Changes in Total Cholesterol
timeFrame: Baseline and 10 weeks
measure: Changes in High density lipoprotein (HDL cholesterol)
timeFrame: Baseline and 10 weeks
measure: Changes in Low density lipoprotein (LDL cholesterol)
timeFrame: Baseline and 10 weeks
measure: Changes in Triglycerides
timeFrame: Baseline and 10 weeks
measure: Changes in aspartate aminotransferase (AST)
timeFrame: Baseline and 10 weeks
measure: Changes in alanine transaminase (ALT)
timeFrame: Baseline and 10 weeks
measure: Changes in albumin
timeFrame: Baseline and 10 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Chinara Tate
role: PRINCIPAL_INVESTIGATOR
References: