Ketogenic Diet for Anorexia

Overseen By Megan Shott, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Pregnancy, Psychosis, Diabetes, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will investigate the effects of therapeutic ketogenic diet (TKD) on eating behavior including drive to restrict, body dissatisfaction, mood and anxiety in individuals with anorexia nervosa who have been weight normalized (body mass index of 17.5 or greater) but continue to struggle with eating disorder behaviors including a high drive for thinness and body dissatisfaction.

Will I have to stop taking my current medications?

The trial allows participants to continue taking certain psychiatric medications, including antidepressants, anxiolytics (medications for anxiety), atypical antipsychotics, and mood stabilizers. If you are on other types of medications, the protocol does not specify whether you need to stop them.

What data supports the effectiveness of the treatment Therapeutic Ketogenic Diet for Anorexia?

The ketogenic diet has been shown to help manage epilepsy and has potential benefits for other neurological conditions like Parkinson's and Alzheimer's diseases. This suggests it might have positive effects on brain health, which could be relevant for treating anorexia. ^{1 2 3 4 5}

Is the ketogenic diet generally safe for humans?

The ketogenic diet has been studied for safety in children and infants with epilepsy, and it is considered safe when carefully managed by a healthcare team. It is important to have medical supervision to monitor health and nutritional needs. ^{2 4 6 7 8}

How is the Therapeutic Ketogenic Diet treatment different from other treatments for anorexia?

The Therapeutic Ketogenic Diet is unique because it is a high-fat, low-carbohydrate diet that changes the body's metabolism by increasing ketone levels, which is different from typical treatments that do not focus on metabolic changes. This diet has been used successfully for other conditions like epilepsy and certain metabolic disorders, suggesting it may offer a novel approach for anorexia by altering brain and body chemistry. ^{1 2 4 5 9}

Research Team

Guido Frank, MD

Principal Investigator

University of California, San Diego

Eligibility Criteria

This trial is for individuals aged 18-45 with a history of anorexia nervosa, who are weight recovered (BMI > 17.5) but still exhibit eating disorder behaviors. Participants must speak English, consent to study procedures, and be able to take certain psychiatric medications if needed. Pregnant or breastfeeding individuals, those with certain medical conditions or substance use disorders, or those unable to follow the diet cannot participate.

Inclusion Criteria

History of anorexia nervosa according to DSM-5 criteria

I am between 18 and 45 years old.

English is primary spoken language

Exclusion Criteria

I have a brain condition like dementia or injury that affects my thinking.

Pregnancy or lactation

My blood tests for kidney, liver, and electrolytes are normal.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ketosis Induction

A 2-week therapeutic ketogenic diet induction to establish nutritional ketosis

2 weeks

Weekly assessments for ketosis and symptoms

Treatment

Continuation of the therapeutic ketogenic diet for 12 weeks with weekly assessments

12 weeks

Weekly visits for weight and symptom assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 visit (in-person)

Treatment Details

Interventions

• Therapeutic Ketogenic Diet

Trial Overview The study examines how a therapeutic ketogenic diet affects eating behavior in people with anorexia nervosa who have normalized their weight yet struggle with body dissatisfaction and a high drive for thinness. It looks at mood changes and anxiety related to eating behaviors during the diet.

Participant Groups

Group I: Therapeutic Ketogenic Diet Experimental Treatment 1 Intervention

A 2-week therapeutic ketogenic diet (TKD) induction will be implemented to establish nutritional ketosis (the goal are BHB blood levels of 0.5-3.0 millimoles per liter \[mmol/L\]). After establishing the ketotic state, study participants will continue TKD for 12 weeks.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Findings from Research

In a mouse model of malignant glioma, a ketogenic diet (KetoCal®) significantly increased survival by approximately 5 days compared to a standard diet, indicating its potential as a supportive treatment in cancer therapy.

The combination of the ketogenic diet and radiation therapy showed more than additive effects, with tumor growth significantly reduced in most mice on the ketogenic diet, suggesting that metabolic changes from the diet could enhance the effectiveness of conventional cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ketogenic diet is an effective adjuvant to radiation therapy for the treatment of malignant glioma. Abdelwahab, MG., Fenton, KE., Preul, MC., et al.[2022]

In a retrospective analysis of 14 patients on the ketogenic diet (KD) for epilepsy, 3 patients became seizure-free and 7 experienced a reduction of at least 50% in their seizures, demonstrating the diet's potential efficacy in managing resistant epilepsy.

Despite positive outcomes, some patients discontinued the KD due to issues like frequent infections, family concerns, and financial difficulties, highlighting the need for ongoing support and consideration of individual circumstances in treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketogenic diet experience at Ondokuz Mayıs University. Tekin, E., Serdaroğlu, FM., Şahin, Ş., et al.[2021]

The study provides 23 consensus-based recommendations for safely and effectively administering ketogenic diet parenteral nutrition (KD-PN) in emergency situations, emphasizing careful monitoring and evaluation of risks and benefits.

KD-PN should be initiated in an intensive care unit and started gradually to minimize complications, with a focus on transitioning back to enteral feeding as soon as it is appropriate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal clinical management of children receiving ketogenic parenteral nutrition: a clinical practice guide. van der Louw, E., Aldaz, V., Harvey, J., et al.[2021]

The ketogenic diet (KD) is an effective medical nutrition therapy for treating epilepsy, which can significantly impact health outcomes in individuals with this condition.

The study emphasizes the importance of following established guidelines for nutrition care, including diet history, assessment, therapy, and follow-up, particularly in pediatric patients undergoing KD therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term management of the ketogenic diet: seizure monitoring, nutrition, and supplementation. Zupec-Kania, B., Zupanc, ML.[2017]

The ketogenic diet (KD) is known for its very low carbohydrate intake, which may have therapeutic benefits for various health conditions.

Research into the KD's effects is ongoing, highlighting its potential applications beyond weight loss, including in areas like epilepsy and metabolic disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial for "The Role of Ketogenic Diet in Human Health and Diseases": The Multifaceted Impact of Ketogenic Diets on Health and Disease. Watanabe, M., Savastano, S., Lubrano, C., et al.[2023]

In a study of 199 patients with refractory epilepsy, the ketogenic diet (KD) demonstrated significant efficacy, with 58% of patients experiencing a reduction in seizure frequency of over 50% after 6 months, and 33% becoming seizure-free.

While the KD is generally safe and effective, with most complications being mild, there were five reported deaths, highlighting the need for careful monitoring of patients, especially those with symptomatic and partial epilepsies who may have a higher risk of relapse after discontinuation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the ketogenic diet for intractable childhood epilepsy: Korean multicentric experience. Kang, HC., Kim, YJ., Kim, DW., et al.[2022]

The ketogenic diet (KD) is highly effective for infants under 1.5 years with epilepsy, showing a higher rate of seizure freedom compared to older children, with 34.5% of infants becoming seizure-free at 3 months versus 19% in older children.

The KD was well tolerated in infants, with no significant safety concerns, and acceptance of the diet was better in infants before they started solid foods, suggesting that early implementation of the KD may be beneficial for managing epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ketogenic diet in infants--Advantages of early use. Dressler, A., Trimmel-Schwahofer, P., Reithofer, E., et al.[2022]

The ketogenic diet (KD) is considered safe and effective for treating childhood epilepsies, including in neonates and infants, challenging the perception that it is only a last-line therapy.

There is a call for further research to explore the potential of the KD as a first-line or early treatment option for severe epilepsies in infants, suggesting it may be beneficial with fewer anticonvulsants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the ketogenic diet in neonates and infants. Rubenstein, JE.[2017]

The ketogenic diet (KD) significantly improved symptoms such as movement disorders and seizure control in four patients with GLUT1 deficiency syndrome, highlighting its efficacy as a treatment.

The study emphasizes the importance of recognizing GLUT1 deficiency syndrome for proper management, as well as the need for diet compliance, especially in school-age children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketogenic Diet in Patients with GLUT1 Deficiency Syndrome. Sandu, C., Burloiu, CM., Barca, DG., et al.[2020]

References

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

The ketogenic diet is an effective adjuvant to radiation therapy for the treatment of malignant glioma. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

Ketogenic diet experience at Ondokuz Mayıs University. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Optimal clinical management of children receiving ketogenic parenteral nutrition: a clinical practice guide. [2021]

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

Long-term management of the ketogenic diet: seizure monitoring, nutrition, and supplementation. [2017]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Editorial for "The Role of Ketogenic Diet in Human Health and Diseases": The Multifaceted Impact of Ketogenic Diets on Health and Disease. [2023]

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

Efficacy and safety of the ketogenic diet for intractable childhood epilepsy: Korean multicentric experience. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

The ketogenic diet in infants--Advantages of early use. [2022]

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

Use of the ketogenic diet in neonates and infants. [2017]

9. Romania pubmed.ncbi.nlm.nih.gov

Ketogenic Diet in Patients with GLUT1 Deficiency Syndrome. [2020]