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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a ketogenic diet (a low-carb, high-fat eating plan) can aid individuals with anorexia nervosa in a high-level care program. Participants will either follow this special diet or continue their usual treatment for 14 weeks, with researchers regularly monitoring changes in their symptoms. The goal is to determine if the ketogenic diet provides any long-term benefits for managing anorexia symptoms. Individuals diagnosed with anorexia nervosa and receiving care at a specific treatment center may be suitable for this study. As an unphased trial, this study presents a unique opportunity to investigate innovative dietary approaches for managing anorexia symptoms.

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 prior data suggests that the Therapeutic Ketogenic Diet is safe for individuals with anorexia nervosa?

Research has shown that the ketogenic diet, high in fats and low in carbohydrates, might be well-tolerated by individuals with anorexia nervosa. Studies have found that this diet can improve mood and mental health symptoms. For instance, one study reported significant mental health improvements in most patients who followed the ketogenic diet for four months. Additionally, a case report described a person with long-term anorexia nervosa who experienced lasting recovery after adopting the ketogenic diet.

While these studies provide limited information on side effects, research on the diet for other conditions suggests it might be safe for short-term use. However, because the ketogenic diet alters how the body obtains energy, some individuals might initially feel tired or notice mood changes. It is essential to consult a healthcare provider before making major dietary changes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for anorexia, which often involve therapy and sometimes medications like antidepressants, the therapeutic ketogenic diet (TKD) offers a unique dietary approach. This diet is high in fats and low in carbohydrates, which can lead to a state of ketosis where the body burns fat for fuel instead of carbs. Researchers are excited because this metabolic shift might help stabilize mood and energy levels, potentially reducing some symptoms of anorexia. Additionally, the structured support, including regular meetings with doctors and dieticians, alongside peer counseling, could provide a comprehensive support system that enhances recovery.

What evidence suggests that the Therapeutic Ketogenic Diet might be an effective treatment for anorexia?

Research has shown that the ketogenic diet might help people with anorexia nervosa. In one study, patients on this diet showed significant improvement in their mental health after four months. Another report described a person with long-term anorexia who experienced lasting recovery after following a ketogenic diet. This trial will compare the Therapeutic Ketogenic Diet (TKD) with Treatment as Usual (TAU). The TKD may help by changing how the body uses energy and affecting brain chemicals, which can boost mood and lower anxiety. Early findings suggest that the ketogenic diet can decrease the urge to avoid eating and improve body image. While more research is needed, these initial results are promising for those considering this diet. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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) 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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11409850/

Therapeutic ketogenic diet as treatment for anorexia nervosa A pilot study showing therapeutic ketogenic diet and ketamine infusion effects in the treatment of chronic persistent eating disorder psychopathology in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06000774

Therapeutic Ketogenic Diet in Anorexia Nervosa This study will investigate the effects of therapeutic ketogenic diet (TKD) on eating behavior including drive to restrict, body dissatisfaction, mood and ...

3. news.stanford.edu news.stanford.edu/stories/2025/04/keto-diet-therapy-mental-illness-research

Stanford Medicine expert shares five key insights on keto ... After four months on the ketogenic diet, most of the patients showed significant improvement in their psychiatric symptoms, a reduction in ...

4. link.springer.com link.springer.com/article/10.1007/s40519-022-01455-x

Ketogenic diet and ketamine infusion treatment to target ... A case report in a person with long-standing anorexia nervosa showed sustained recovery after ketogenic diet and ketamine treatment.

5. journalofmetabolichealth.org journalofmetabolichealth.org/index.php/jmh/article/view/84/254

Animal-based ketogenic diet puts severe anorexia nervosa ... This case series is the first to document treatment of anorexia with unimodal ketogenic diet intervention and raises provocative questions.