Ketogenic Diet for Anorexia Nervosa

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Antidepressants, Antipsychotics

Disqualifiers: Bipolar, Psychosis, Substance abuse, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 14 weeks

90 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a longitudinal study with an open design in weight recovered anorexia nervosa (wrAN) individuals. Healthy controls (HC) will also be assessed. Study participants will be carefully assessed and will have 18F-fluorodeoxyglucose (\[18F\]FDG) positron emission tomography (PET) scans for assessment of regional brain glucose uptake. The wrAN group will be compared to healthy controls. Participants in the wrAN group will then complete 14 weeks of therapeutic ketogenic diet (TKD). At the end of the TKD study, participants will have assessments and a second \[18F\]FDG and TMS/EEG scan. Study participants will be followed over six months after the intervention. This follow-up procedure will help determine whether symptom improvement will be stable or worsen in individuals who choose to continue or discontinue the TKD intervention. This will be a naturalistic follow-up.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants must stop taking their current medications. However, healthy controls cannot be taking any medication, and those with weight recovered anorexia nervosa should not have major medical illnesses that require medication.

What data supports the effectiveness of the treatment Therapeutic Ketogenic Diet (TKD) for Anorexia Nervosa?

The ketogenic diet has been shown to be effective in managing epilepsy and certain metabolic disorders, and it may help with other neurological conditions by altering brain metabolism. While not directly studied for anorexia nervosa, its success in other conditions suggests potential benefits. ^{1 2 3 4 5}

Is the ketogenic diet safe for humans?

The ketogenic diet, used primarily for epilepsy, can cause side effects like stomach issues and affect growth and nutrition, especially in children. It is generally managed by a healthcare team to monitor and address these issues. ^{1 3 6 7 8}

How is the Therapeutic Ketogenic Diet (TKD) different from other treatments for anorexia nervosa?

The Therapeutic Ketogenic Diet (TKD) is unique because it is a high-fat, low-carbohydrate diet that alters metabolism by increasing ketone bodies in the blood, which is different from traditional treatments for anorexia nervosa that typically focus on psychological therapy and nutritional rehabilitation. This diet has been used successfully in other conditions like epilepsy and metabolic disorders, suggesting it may offer a novel approach by potentially stabilizing brain function and energy levels. ^{1 2 3 5 9}

Eligibility Criteria

This trial is for individuals who have recovered from anorexia nervosa (wrAN) and healthy controls. Participants with wrAN will be compared to the healthy group, then follow a ketogenic diet for 14 weeks. They must be willing to undergo brain scans before and after the diet, and participate in a six-month follow-up.

Inclusion Criteria

I am 18-45, recovered from anorexia with a BMI over 17.5, and still show eating disorder behaviors.

Exclusion Criteria

I have never had a psychiatric illness, am not on medication, and have no close relatives with an eating disorder.

No subject in either group will have or be: mental retardation or pervasive developmental disorder, organic brain syndrome, dementia, psychotic disorder, bipolar disorder, somatic symptom, conversion disorder, current alcohol or substance use disorder, indication of major medical illness including a history of seizure disorder, pregnant or nursing at the time of the study, a history of traumatic brain injury, diabetes mellitus or other metabolic disorders that could worsen on a ketogenic diet, intracranial or any other metal object within or near the head that cannot be safely removed, excluding the mouth, implanted neurostimulators, intracardiac lines, or heart disease

Weight Recovered Anorexia Nervosa (AN): Current pregnancy or nursing (will have to agree to contraceptive measures if sexually active), Lifetime history of bipolar I disorder or psychosis, Current substance abuse or dependence in the past 3 months, Psychotic illness/other organic brain syndromes, dementia, somatization disorders or conversion disorders, History of significant head trauma, Indication of intellectual disability or autism spectrum disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo initial assessments including 18F-fluorodeoxyglucose (FDG) PET scans to assess regional brain glucose uptake

1-2 weeks

1 visit (in-person)

Treatment

Participants in the weight recovered anorexia nervosa group complete 14 weeks of therapeutic ketogenic diet (TKD)

14 weeks

Regular visits for monitoring and blood ketosis measurements

Post-Treatment Assessment

Participants undergo assessments and a second 18F-FDG and TMS/EEG scan to evaluate changes

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored over six months to determine the stability of symptom improvement and adherence to TKD

6 months

Naturalistic follow-up with periodic check-ins

Treatment Details

Interventions

• Therapeutic Ketogenic Diet (TKD)

Trial Overview The study tests how a therapeutic ketogenic diet (TKD) affects brain glucose uptake in those recovered from anorexia nervosa using PET scans. It's designed to see if changes after the diet are maintained or reversed over six months without intervention.

Participant Groups

Group I: Therapeutic Ketogenic Diet Experimental Treatment 1 Intervention

Subjects will be placed on a therapeutic ketogenic diet (TKD) for a duration of 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 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]

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]

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) has been effectively used to treat intractable epilepsy in children, with 802 patients undergoing various dietary interventions including KD, modified Atkins diet (MAD), and low glycemic index treatment (LGIT) at Severance Hospital.

Among the patients, 61% followed the KD, indicating its popularity and potential efficacy compared to other dietary approaches like MAD and LGIT, which were used by 18.3% and 20.7% of patients, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketogenic Diet for Children with Epilepsy: A Practical Meal Plan in a Hospital. Lee, E., Kang, HC., Kim, HD.[2022]

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]

Children with intractable epilepsy on a ketogenic diet (KD) reported lower quality of life scores compared to those on normal diets, indicating potential negative impacts on their overall well-being (P = 0.01).

While patients on the KD showed a trend towards more gastrointestinal symptoms and lower growth metrics (height, weight, BMI z scores), these findings were not statistically significant, suggesting that while there are concerns, they may not be clinically impactful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketogenic Diets in Children With Intractable Epilepsy and its Effects on Gastrointestinal Function, Gut Microbiome, Inflammation, and Quality of Life. Menzies, J., Sundararaj, A., Cardamone, M., et al.[2023]

In a study of 16 pediatric patients with intractable epilepsy, 56% showed significant improvement in seizure control while on a ketogenic diet (KD), with three children becoming completely seizure-free.

The non-fasting ketogenic diet was found to be safe and effective, with most children gaining weight and only experiencing mild, reversible side effects such as hypoglycemia and vomiting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of non-fasting ketogenic diet protocol in the management of intractable epilepsy in pediatric patients: a single center study from Saudi Arabia. Alameen Ali, H., Muthaffar, O., AlKarim, N., et al.[2022]

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]

A 14-year-old patient with GLUT1 deficiency syndrome successfully received parenteral ketogenic dietary treatment (PN-KDT) for five days after undergoing urgent laparoscopic appendectomy, demonstrating the feasibility of this approach in acute surgical settings.

The patient showed rapid recovery without worsening neurological symptoms, highlighting the effectiveness and safety of PN-KDT as a temporary solution when traditional oral ketogenic diets are not possible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Classic ketogenic diet in parenteral nutrition in a GLUT1DS patient: Doing more with less in an acute surgical setting. De Giorgis, V., Ferraris, C., Brena, ML., et al.[2023]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Ketogenic diet experience at Ondokuz Mayıs University. [2021]

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

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

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

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

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Ketogenic Diet for Children with Epilepsy: A Practical Meal Plan in a Hospital. [2022]

5. Romania pubmed.ncbi.nlm.nih.gov

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

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

Ketogenic Diets in Children With Intractable Epilepsy and its Effects on Gastrointestinal Function, Gut Microbiome, Inflammation, and Quality of Life. [2023]

7. England pubmed.ncbi.nlm.nih.gov

The efficacy of non-fasting ketogenic diet protocol in the management of intractable epilepsy in pediatric patients: a single center study from Saudi Arabia. [2022]

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

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

9. Switzerland pubmed.ncbi.nlm.nih.gov

Classic ketogenic diet in parenteral nutrition in a GLUT1DS patient: Doing more with less in an acute surgical setting. [2023]