Metabolic Diet for Anorexia Nervosa

Overseen by Chinara Tate

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Metabolic Diet treatment for anorexia nervosa?

Research shows that various dietary approaches, including a Mediterranean Diet and monitored nutritional therapy, can lead to significant weight gain and improved body composition in patients with anorexia nervosa. These findings suggest that structured dietary interventions, like the Metabolic Diet, may be effective in supporting recovery. ^{1 2 3 4 5}

Is the Metabolic Diet safe for humans?

The Mediterranean Diet, which may be similar to the Metabolic Diet, was studied in adolescents with anorexia nervosa and showed improvements in weight and body composition without significant safety concerns. However, enteral nutrition (feeding through a tube) in anorexia nervosa patients sometimes caused temporary low phosphate levels and mild liver enzyme changes, but these were not linked to serious health issues. ^{3 4 6 7 8}

How does the Metabolic Diet treatment for anorexia nervosa differ from other treatments?

The Metabolic Diet for anorexia nervosa is unique because it focuses on metabolic care and may involve a specific balance of nutrients, such as lower carbohydrates and higher fats, to promote weight gain and minimize refeeding complications. Unlike standard refeeding diets, which lack a defined approach, this diet aims to address metabolic changes and improve body composition and energy expenditure. ^{3 4 6 9 10}

Research Team

Chinara Tate

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

I am between 18 and 40 years old.

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

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)

Trial Timeline

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)

Treatment Details

Interventions

• Metabolic Diet (Dietary Supplement)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Body composition changes during recovery from anorexia nervosa: comparison of two dietary regimes. [2018]

2. England pubmed.ncbi.nlm.nih.gov

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

3. Switzerland 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. [2023]

4. England 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. [2020]

5. Spain pubmed.ncbi.nlm.nih.gov

[Our experience in the nutritional treatment of anorexia nervosa (1989-1991)]. [2013]

6. England 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. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Enteral nutrition in anorexia nervosa. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Caffeine, artificial sweetener, and fluid intake in anorexia nervosa. [2021]

9. Ireland pubmed.ncbi.nlm.nih.gov

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

10. Czech Republic pubmed.ncbi.nlm.nih.gov

[Anorexia nervosa--the views of the internist]. [2010]