Metabolic Diet for Anorexia Nervosa

Overseen By Chinara Tate

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Metabolism affecting drugs

Disqualifiers: Psychotic disorders, Bipolar, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the Metabolic Diet to determine if it helps women with anorexia nervosa maintain a stable weight after regaining a healthy weight. Researchers will focus on the diet's safety and effectiveness while monitoring changes in metabolism and psychological well-being. Participants will meet weekly with a dietitian to follow the diet and will receive medical check-ups. Women who have recently reached a healthy weight after anorexia nervosa or women without any history of eating disorders are suitable candidates for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future treatment options for anorexia nervosa.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications that could affect metabolism for 2 weeks before the main study visit.

What prior data suggests that the Metabolic Diet is safe for women with anorexia nervosa?

Research has shown that the Metabolic Diet aims to help women with anorexia nervosa maintain stable weight after regaining it. Although specific safety information about this diet is limited, some studies suggest that increased calorie intake can improve recovery without raising the risk of refeeding syndrome. Refeeding syndrome is a serious condition that can occur when a malnourished person begins eating again.

Nutrition plans for anorexia nervosa typically involve careful monitoring to prevent complications. In this trial, participants will meet with a dietitian weekly and undergo regular medical check-ups to monitor for side effects or health changes. As this trial is in an early stage without established safety data, close monitoring will allow for the quick addressing of any potential issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Metabolic Diet for anorexia nervosa is unique because it focuses on nutritional approaches rather than the typical psychological or pharmacological treatments like cognitive behavioral therapy or medications such as antidepressants. Unlike those methods that often address symptoms or psychological roots, this diet aims to directly influence the body's metabolism and restore healthy eating patterns. Researchers are excited because this could offer a more holistic and potentially more effective way to sustain weight recovery and improve overall health in women recovering from anorexia nervosa, addressing the underlying metabolic needs rather than just the psychological ones.

What evidence suggests that the Metabolic Diet might be an effective treatment for anorexia nervosa?

Research has shown that the Metabolic Diet, which participants in this trial may follow, might help women with anorexia nervosa maintain their weight after regaining a normal weight. Early findings suggest this diet could also ease concerns about eating and body image. It focuses on how the body uses energy, which can differ in people with anorexia. By addressing these areas, the diet aims to maintain weight without causing a relapse. Although more research is needed, early results are promising for supporting long-term recovery. ^{2 3 6 7 8}

Who Is on the Research Team?

Chinara Tate

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for adult women aged 18-40 who have recovered from anorexia nervosa to a healthy weight within the last 6 months. They must speak English, be medically stable with normal vital signs and blood tests, and not be on metabolism-affecting medications. Women without eating disorders can also join. Those with active depression, psychosis, bipolar disorder, recent suicide attempts or acute risk, significant medical conditions like diabetes or pregnancy are excluded.

Inclusion Criteria

Speaks English

History of DSM-5 diagnosis of Anorexia Nervosa (WR-AN only)

I have regained weight to a healthy level after being underweight.

Exclusion Criteria

I do not have any major illnesses like diabetes or am not pregnant.

Active DSM-5 substance use disorders

Current/lifetime diagnosis of DSM-5 eating disorders (HC only)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants follow the Metabolic Diet for 8 weeks, meeting weekly with a dietitian and physician to monitor adherence and health parameters

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Metabolic Diet

Trial Overview

The study examines the Metabolic Diet's safety and effectiveness in maintaining weight stability in women who've recently gained back weight after being underweight due to anorexia nervosa. Participants will work with dietitians weekly to follow this special diet while their health and psychological changes are monitored.

How Is the Trial Designed?

Group I: Women with anorexia nervosa Active Control 1 Intervention

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

Group II: Women with no history of eating disorders Active Control 1 Intervention

adult women with no history of eating disorders

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

In a study involving 24 hospitalized patients aged 15-25 with anorexia nervosa, a lower carbohydrate/high fat enteral formula significantly reduced the incidence of hypophosphatemia compared to a standard enteral formula, indicating a safer nutritional approach during rehabilitation.

While both formulas resulted in decreased serum phosphate levels, the lower carbohydrate/high fat formula maintained higher phosphate levels at Week 1, suggesting it may better protect against refeeding complications without affecting weight gain or hospital stay duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A standard enteral formula versus an iso-caloric lower carbohydrate/high fat enteral formula in the hospital management of adolescent and young adults admitted with anorexia nervosa: a randomised controlled trial. Parker, EK., Flood, V., Halaki, M., et al.[2021]

Enteral nutrition via the nasogastric route in 9 subjects with anorexia nervosa led to significant improvements in body weight (averaging 8.22 kg/month) and increases in mid-arm muscle circumference and tricipital skinfold, indicating effective nutritional rehabilitation.

While enteral nutrition was generally well-tolerated, it did result in occasional transient hypophosphatemia and moderate increases in liver enzymes, which were not linked to any clinical issues, suggesting a favorable safety profile overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enteral nutrition in anorexia nervosa. Bufano, G., Bellini, C., Cervellin, G., et al.[2017]

In a study of 70 participants with anorexia nervosa, the consumption of artificial sweeteners (like aspartame), caffeine, and water did not significantly differ between those with the restricting subtype and those with the binge-purge subtype.

Daily water intake was linked to the frequency of vomiting in patients with the binge-purge subtype, suggesting a modest relationship between fluid consumption and purging behaviors, but overall, these substances showed variable consumption patterns among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caffeine, artificial sweetener, and fluid intake in anorexia nervosa. Marino, JM., Ertelt, TE., Wonderlich, SA., et al.[2021]

In a pilot study of 8 adolescents with Anorexia Nervosa, adherence to the Mediterranean Diet was associated with significant weight gain and improvements in lean body mass and resting energy expenditure over six months.

While the increase in adherence to the Mediterranean Diet, as measured by the KIDMED score, was not statistically significant, the diet still showed potential as an effective nutritional strategy for weight restoration and recovery in patients with Anorexia Nervosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to a Mediterranean Diet, Body Composition and Energy Expenditure in Outpatients Adolescents Diagnosed with Anorexia Nervosa: A Pilot Study. Cinelli, G., Croci, I., De Santis, GL., et al.[2023]

Nutritional therapy significantly improved the nutritional state and Body Mass Index (BMI) of 66 patients with anorexia nervosa over a treatment period from 1989 to 1991, indicating its efficacy in addressing malnutrition.

The study found that while all patients showed improvement in anthropometric measures, only outpatients experienced an increase in arm muscle circumference, suggesting different responses to treatment based on patient status (inpatient vs outpatient).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Our experience in the nutritional treatment of anorexia nervosa (1989-1991)]. Megía, A., Gil Canalda, I., Luna, R., et al.[2013]

Studies on carbohydrate metabolism in anorexia nervosa show that metabolic changes are similar to those seen in caloric and carbohydrate restriction, indicating that these changes are not unique to anorexia.

Restoring normal body weight in individuals with anorexia nervosa leads to the normalization of metabolic measures, suggesting that the metabolic impairments are reversible with weight restoration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbohydrate metabolism and its regulatory hormones in anorexia nervosa. Casper, RC.[2019]

Complete parenteral nutrition effectively supports weight gain in patients with anorexia nervosa, as demonstrated by a weight increase of 1.5-1.7 kg after 18-57 days of treatment in five patients.

While psychological support is crucial during treatment, it does not fully prevent relapse, as two out of five patients experienced a return of symptoms after leaving the hospital.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Anorexia nervosa--the views of the internist]. Hertlová, M., Lata, J., Vodicka, J., et al.[2010]

In a study of 12 patients with anorexia nervosa, a high protein diet (20% energy from protein) did not lead to better recovery outcomes compared to a lower protein diet (10% energy from protein), indicating that a high protein intake is not necessary for nutritional rehabilitation.

Both diets resulted in similar weight gain and metabolic changes, with about two-thirds of the weight gained being lean tissue, suggesting that overall caloric intake is more important than protein percentage in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Body composition changes during recovery from anorexia nervosa: comparison of two dietary regimes. Forbes, GB., Kreipe, RE., Lipinski, BA., et al.[2018]

The study involved 20 patients with anorexia nervosa who were treated with closely monitored normal nutrition and bedrest, resulting in satisfactory weight gain for all patients within acceptable time limits.

The treatment included the use of chlorpromazine medication, and the progress of one 14-year-old girl was highlighted, demonstrating the effectiveness of this nutritional approach in a clinical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anorexia nervosa: dietary treatment and re-establishment of body weight in 20 cases studied on a metabolic unit. Marshall, MH.[2019]

Refeeding a low-fat diet in female rats with anorexia nervosa led to rapid weight gain despite lower energy intake, but this weight gain was unhealthy, resulting in significantly higher liver fat accumulation compared to controls.

The study suggests that a lower carbohydrate, higher fat diet may be more beneficial during refeeding for anorexia nervosa, as it was found to be equally palatable and acceptable in a clinical trial with adolescent female patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight restoration on a high carbohydrate refeeding diet promotes rapid weight regain and hepatic lipid accumulation in female anorexic rats. Giles, ED., Hagman, J., Pan, Z., et al.[2020]

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