Ketogenic Diet for Mental Illnesses

Overseen By Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Clozapine

Disqualifiers: Pregnancy, Insulin dependence, Cardiovascular dysfunction, Substance abuse, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

120 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial allows participants to continue taking their current psychiatric medications if they are on a stable dose. You may need to switch medications before enrolling, but you should be stable enough to follow the study procedures.

What data supports the effectiveness of the treatment LCHF Ketogenic Diet for mental illnesses?

Research suggests that the ketogenic diet, known for its success in treating epilepsy, may also help with mental illnesses by improving brain metabolism and stability. It has shown potential benefits in psychiatric disorders by enhancing brain function and reducing inflammation. ^{1 2 3 4 5}

Is the ketogenic diet safe for humans?

The ketogenic diet has been used safely for many years, especially in treating epilepsy in children, and studies suggest it is generally safe for humans. However, it is important to monitor for potential side effects like nutrient deficiencies and digestive issues. ^{2 3 4 6 7}

How does the ketogenic diet treatment differ from other treatments for mental illnesses?

The ketogenic diet is unique because it uses a high-fat, low-carbohydrate approach to provide the brain with ketones, an alternative and more efficient fuel than glucose. This diet may improve brain function and stability, offering potential benefits for mental illnesses by enhancing metabolism and reducing inflammation, unlike traditional treatments that often focus on neurotransmitter balance. ^{1 2 3 4 5}

What is the purpose of this trial?

The goal of this randomized clinical trial is to be adequately powered to evaluate the effect of ketogenic metabolic therapy on the quality of life in serious mental illness, schizophrenia, bipolar disorder, major depressive disorder.

Research Team

Shebani Sethi, MD, ABOM

Principal Investigator

Stanford University

Michael Snyder, PhD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for U.S. residents with schizophrenia, bipolar disorder, or major depressive disorder who are clinically stable and not hospitalized in the past 3 months. They must have a moderate to severe condition score (PHQ-9 >10 or BPRS >40) and can be on stable psychiatric medication. Excluded are those with certain medical conditions, substance abuse issues, recent ketogenic dieting, or participation in other trials.

Inclusion Criteria

My depression is moderate to severe, stable, and I haven't been hospitalized recently.

I have bipolar disorder, not mild, stable, and no recent hospital visits.

I am on a stable dose of antidepressants or psychiatric meds, and possibly sleep meds for at least 4 weeks.

Exclusion Criteria

I have a family history of very high cholesterol.

I have severe kidney or liver problems.

I have not been in a clinical trial with investigational drugs that could affect this study in the last month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a ketogenic diet for 12 weeks with monitoring of physical and psychological health and coaching support

12 weeks

Weekly visits (in-person or virtual)

Crossover Treatment

Participants initially on their usual diet crossover to a ketogenic diet for 12 weeks with monitoring and support

12 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LCHF Ketogenic Diet

Trial Overview The study compares the effects of a Low-Carbohydrate High-Fat (LCHF) Ketogenic Diet versus a standard Diet-as-Usual (DAU) on quality of life in patients with serious mental illnesses like schizophrenia and bipolar disorder. It's randomized to determine if this dietary intervention can improve health outcomes.

Participant Groups

Group I: Arm 2: DAU- Ketogenic Diet Crossover Experimental Treatment 2 Interventions

Participants will follow 12 weeks of their usual diet (Diet-as-Usual, DAU). Then, participants will crossover and follow 12 weeks of the ketogenic diet. Monitoring of physical and psychological health and coaching support will occur throughout participation.

Group II: Arm 1: Ketogenic Diet Only Experimental Treatment 1 Intervention

Participants will follow 12 weeks of the ketogenic diet, with monitoring of physical and psychological health and coaching support.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

The ketogenic diet (KD), characterized by high fat and low carbohydrate intake, has shown promise in reducing symptoms of various psychiatric disorders based on a review of 14 studies.

While the results indicate a positive response for individuals adhering to the KD, further research is needed to clarify the specific benefits and mechanisms of action in psychiatric conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of the ketogenic diet in the treatment of psychiatric disorders. Tillery, EE., Ellis, KD., Threatt, TB., et al.[2023]

In a study of 31 adults with severe mental illnesses, a ketogenic diet significantly improved depression and psychosis symptoms, as shown by reductions in Hamilton Depression Rating Scale scores from 25.4 to 7.7 and PANSS scores from 91.4 to 49.3, all with P < 0.001.

The ketogenic diet was well-tolerated and also led to improvements in metabolic health markers, including weight, blood pressure, blood glucose, and triglycerides, indicating potential benefits beyond mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Ketogenic Diet for Refractory Mental Illness: A Retrospective Analysis of 31 Inpatients. Danan, A., Westman, EC., Saslow, LR., et al.[2022]

The ketogenic diet (KD) has shown potential benefits in animal models for various mental disorders, including significant reductions in anxiety and depression-like behaviors, but results in human studies are mixed and not conclusive.

Currently, there is insufficient evidence to recommend KD as a treatment for mental disorders due to limitations in existing studies, such as reliance on animal models and lack of standardized measures like ketone levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Current Status of the Ketogenic Diet in Psychiatry. Bostock, EC., Kirkby, KC., Taylor, BV.[2020]

Individuals with schizophrenia, even those who are medication-naïve, show disrupted insulin and glucose metabolism, increasing their risk for Type 2 diabetes and cardiovascular diseases.

A ketogenic diet may offer significant benefits for people with schizophrenia by improving brain metabolism, cognitive function, and overall metabolic health, suggesting a need for further clinical trials to explore its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Ketogenic Metabolic Therapy on the Brain in Serious Mental Illness: A Review. Sethi, S., Ford, JM.[2022]

The ketogenic diet (KD) is considered a relatively safe treatment for refractory childhood epilepsy, with severe adverse effects occurring in less than 0.5% of children, and no deaths attributed to the diet.

Common adverse effects include gastrointestinal disturbances and hyperlipidemia, but the main reason for discontinuation of the diet was lack of efficacy rather than safety concerns, highlighting the need for careful medical supervision during its implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of the ketogenic diet used for the treatment of refractory childhood epilepsy: a systematic review of published prospective studies. Cai, QY., Zhou, ZJ., Luo, R., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Ketogenic diet as a metabolic treatment for mental illness. [2023]

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

The use of the ketogenic diet in the treatment of psychiatric disorders. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Ketogenic Diet for Refractory Mental Illness: A Retrospective Analysis of 31 Inpatients. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Current Status of the Ketogenic Diet in Psychiatry. [2020]

5. England pubmed.ncbi.nlm.nih.gov

The Role of Ketogenic Metabolic Therapy on the Brain in Serious Mental Illness: A Review. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and tolerability of the ketogenic diet used for the treatment of refractory childhood epilepsy: a systematic review of published prospective studies. [2018]

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

Antiseizure medication reduction and withdrawal in children with drug-resistant epilepsy after starting the ketogenic diet. [2023]