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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a ketogenic diet can help individuals who have regained weight after anorexia nervosa, an eating disorder characterized by minimal eating and significant weight loss. The study examines how the brain uses glucose before and after participants follow a special high-fat, low-carb diet for 14 weeks. Individuals who have had anorexia, are now at a healthier weight, and exhibit eating disorder-related behaviors may be suitable candidates. The goal is to determine if this diet can prevent the recurrence of symptoms over time. As an unphased trial, this study provides a unique opportunity to contribute to understanding dietary impacts on anorexia recovery.

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 prior data suggests that the therapeutic ketogenic diet is safe for individuals with anorexia nervosa?

Research has shown that the therapeutic ketogenic diet (TKD) is generally well-tolerated by individuals with anorexia nervosa. A small study found that ketosis, which occurs when following a ketogenic diet, might help address key issues of anorexia, such as concerns about eating and body shape. Another early study found that the diet, when combined with other treatments, did not cause any serious side effects.

While these results are encouraging, the safety of the ketogenic diet for this purpose remains under investigation. Participants in earlier studies adhered to the diet without major problems. However, further research is needed to fully understand any long-term effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for anorexia nervosa, which typically include therapy and medications to address psychological and physiological aspects, the Therapeutic Ketogenic Diet (TKD) focuses on dietary intervention by altering metabolism. Researchers are excited about TKD because it shifts the body's energy source from glucose to ketones, which may help stabilize mood and reduce anxiety—a significant challenge in anorexia recovery. Additionally, the ketogenic diet is known for its potential neuroprotective effects, which could offer new hope for improving mental health outcomes in individuals with anorexia nervosa.

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

Research has shown that the therapeutic ketogenic diet (TKD), which participants in this trial will follow, might help people with anorexia nervosa by balancing energy use in the body. In one study, patients on this diet gained over 20 kilograms and experienced reduced anxiety and improved mental health. Another report highlighted a person with long-term anorexia nervosa who achieved lasting recovery after following the ketogenic diet. Additionally, many patients on this diet have demonstrated significant improvement in mental health symptoms, including mood and body image. The diet appears to reduce the urge to self-starve by reaching a state called nutritional ketosis, which can lead to better eating habits. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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) 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]

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]

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 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]

Citations

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pmc.ncbi.nlm.nih.gov

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

Therapeutic ketogenic diet as treatment for anorexia nervosa

The TKD may be an effective treatment intervention for AN to normalize energy homeostasis and remove the need to self-starve for nutritional ketosis. Figure 2 ...

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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 ...

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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.

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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 ...

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journalofmetabolichealth.org

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

Animal-based ketogenic diet puts severe anorexia nervosa ...

Patients exhibited not only improvements in weight, with weight gain of over 20 kg each, but also diminution of anxiety and overall enhanced mental well-being.

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clinicaltrials.gov

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

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 ...

7.

clinicaltrials.ucsd.edu

clinicaltrials.ucsd.edu/trial/NCT06540703

Ketogenic Diet and Brain Response in Anorexia Nervosa

A small study indicated that ketosis might be therapeutic for AN core behaviors such as eating and shape concerns.