Metabolic Diet for Relapse Prevention in Anorexia Nervosa
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metabolic Diet.
- Who it may be relevant to
- Registry conditions: Anorexia Nervosa. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
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.
Interventions
- Dietary supplement 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.
Primary outcome measures
- Number of adverse events [Time frame: 10 weeks]
- Percent completion of food [Time frame: 10 weeks]
- Percent completion of ketone logs [Time frame: Baseline to 10 weeks]
Secondary outcome measures (12)
- Change in Weight [Time frame: Baseline and 10 weeks]
- Change in Eating Disorder Examination Questionnaire (EDE-Q) [Time frame: Baseline and 10 weeks]
- Changes in Anxiety using the Beck Anxiety Inventory (BAI) [Time frame: Baseline and 10 weeks]
- Changes in Mood using the Quick Inventory of Depressive Symptomatology (QIDS) [Time frame: Baseline and 10 weeks]
- Changes in Clinical Impairments using the Clinical Impairment Assessment (CIA) [Time frame: Baseline and 10 weeks]
- Changes in Quality of Life using the Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) from Baseline to 10 Weeks [Time frame: Baseline and 10 weeks]
- Changes in Carbon Dioxide (CO2) [Time frame: Baseline and 10 weeks]
- Changes in Potassium level [Time frame: Baseline and 10 weeks]
- Changes in Sodium level [Time frame: Baseline and 10 weeks]
- Changes in Chloride [Time frame: Baseline and 10 weeks]
- Changes in Calcium [Time frame: Baseline and 10 weeks]
- Changes in Creatine [Time frame: Baseline and 10 weeks]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Icahn School of Medicine at Mount Sinai — New York
Identifiers
NCT: NCT05197309 · STUDY-20-01956