Ketogenic Diet for Anorexia

Overseen By Megan Shott, BS

Age: < 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: 3

Duration: 14 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This will be a 14-week longitudinal study with an open design. A total of 120 individuals will be recruited for an end goal of 60 individuals with anorexia nervosa (AN) who are currently in high level of care treatment at the UCSD Eating Disorder Center partial hospital program (PHP) or intensive outpatient (IOP). Forty individuals will be recruited to the TKD and 20 will be treated with treatment as usual with respect to food intake. The age range will be between 16 and 45 years. All study participants will be carefully assessed and will complete rater and self-assessments at the being at the end of the study period. While in the treatment program, the TKD group will receive catered ketogenic meals via a meal service. After discharging from program, participants will have the option to continue with the meal service or cook for themselves. After establishing ketosis, study participants will continue TKD for 12 weeks. All study participants will be followed over three, six, and twelve months after enrolling in the study, whether initiating TKD or being in the treatment as usual arm. This follow-up procedure will help determine whether symptom improvement is stable or worsens in individuals who choose to continue or discontinue the TKD intervention and in relation to the control group. After ketosis induction over two weeks, study participants will be assessed weekly for ketosis and mood, anxiety, and eating disorder symptoms over twelve weeks.

Will I have to stop taking my current medications?

The trial allows participants to continue taking certain psychiatric medications, including antidepressants, anxiolytics (anti-anxiety medications), 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 be effective in managing epilepsy and has potential benefits for other neurological conditions like Parkinson's and Alzheimer's. This suggests it might help with anorexia by altering brain metabolism and improving brain health. ^{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 properly managed by healthcare professionals. It requires careful monitoring and support from a medical team to ensure nutritional needs are met and to manage any potential side effects. ^{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 may have therapeutic effects on the brain and nervous system. Unlike standard treatments for anorexia, which often focus on psychological and nutritional counseling, this diet alters metabolic processes and has been used successfully in other neurological and metabolic disorders. ^{1 2 4 5 9}

Eligibility Criteria

This trial is for individuals aged 16-45 with anorexia nervosa who are in a partial hospital program or intensive outpatient treatment at the UCSD Eating Disorder Center. Participants will be followed up to twelve months after starting the study.

Inclusion Criteria

Provision of signed and dated informed consent form/parental permission form

I am between 16 and 45 years old.

English is primary spoken language

Exclusion Criteria

Current alcohol use disorder (AUD) or substance use disorder (SUD) according to DSM-5 criteria

Psychosis

My blood pressure is not controlled by medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 14-week therapeutic ketogenic diet (TKD) or treatment as usual, with weekly assessments and meetings.

14 weeks

Weekly visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment at 3 months, 6 months, and 1 year.

12 months

3 visits (virtual)

Treatment Details

Interventions

• Therapeutic Ketogenic Diet

Trial Overview The study compares a Therapeutic Ketogenic Diet (TKD) with standard treatment over 14 weeks. Forty participants will receive ketogenic meals, while twenty follow usual dietary treatments. The effects on mood, anxiety, and eating disorder symptoms will be monitored.

Participant Groups

Group I: Therapeutic Ketogenic Diet (TKD) Study Arm Experimental Treatment 1 Intervention

Participants in the TKD Study Arm will complete 14 weeks of therapeutic ketogenic diet (TKD), weekly weight and ketone measurements, weekly behavioral assessments, and meetings with the study doctor and dietician every week, and peer counseling sessions.

Group II: Treatment as Usual (TAU) Study Arm Active Control 1 Intervention

Participants who consent to be in the Treatment as Usual Study Arm will complete weekly weight and ketone measurements and questionnaires for 14 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]