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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a therapeutic ketogenic diet (a low-carb, high-fat diet) can improve eating behaviors, mood, and anxiety in people with eating disorders. It consists of three parts: one for individuals with anorexia nervosa who are at a healthier weight but still struggle with body image and eating habits, another for those who are underweight with anorexia, and a pilot for individuals with bulimia nervosa who struggle with bingeing and purging. Eligible participants must have been diagnosed with anorexia or bulimia and continue to experience issues like a strong desire to be thin or dissatisfaction with their body. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new dietary approaches for eating disorders.

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.

Is there any evidence suggesting that the therapeutic ketogenic diet is likely to be safe for humans?

Research has shown that the therapeutic ketogenic diet (TKD) might be well tolerated by people with eating disorders such as anorexia. In one study, patients followed this diet for four months and experienced significant improvements in mental health, suggesting they managed the diet well without major issues. Another study indicated that participants maintained a healthy weight while on the diet, further suggesting its manageability.

While these findings are encouraging, it's important to remember that this diet is still under investigation, especially for conditions like anorexia and bulimia. Like any treatment, side effects may occur, but current evidence suggests the diet is generally safe for many people. Those considering this option should consult a healthcare provider to understand its personal implications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the therapeutic ketogenic diet for anorexia because it offers a different approach compared to traditional treatments, which often focus on psychological therapies and nutritional rehabilitation. This diet induces a state of nutritional ketosis, where the body uses ketones instead of glucose for energy, potentially influencing brain chemistry in a way that could reduce symptoms of anorexia. Unlike standard treatments, the ketogenic diet may provide a biological mechanism to target the underlying metabolic and neurological aspects of the condition, offering a novel alternative for those who may not respond well to existing options.

What evidence suggests that the Therapeutic Ketogenic Diet could be effective for anorexia and bulimia?

Studies have shown that the therapeutic ketogenic diet (TKD) might help with eating disorders like anorexia and bulimia. After four months on the diet, many patients experienced a significant reduction in symptoms such as anxiety and mood swings. This diet is believed to alter how the brain uses energy, potentially reducing the urge to binge, purge, or avoid food. A small study found that individuals on a ketogenic diet felt less dissatisfied with their bodies and experienced improved mood. While more research is needed, these early findings are promising for using TKD to treat eating disorders. Participants in this trial will undergo a 2-week TKD induction to establish nutritional ketosis, followed by 12 weeks of continued TKD. ^{1 2 4 5 6}

Who Is on the Research Team?

Guido Frank, MD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

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

English is primary spoken language

Provision of signed and dated informed consent form

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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) 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]

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]

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 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]

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. 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.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06000774?cond=anorexia%20nervosa&term=Ketogenic%20Diet&rank=2

Therapeutic Ketogenic Diet in Anorexia Nervosa We expect especially a reduction in binge eating episodes and associated purging episodes in response to the treatment and in addition to improvement of the ...

6. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT06540703

Ketogenic Diet and Brain Response in Anorexia Nervosa It is hypothesized that TKD will be well tolerated, that participants will remain within the normal weight range (tolerability), and that study ...