Ketogenic Diet for Mental Illness

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Mclean Hospital

Disqualifiers: No longer meeting original criteria

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a ketogenic diet might assist individuals with mental illness. Participants will adhere to the diet, high in fats and low in carbohydrates, for 12 weeks while maintaining any current medications. The goal is to determine if this diet can improve mental health symptoms. It is ideal for those who completed a previous related study and still meet the original eligibility criteria. Participants will receive diet guidance and must track their blood ketone and glucose levels daily. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on the dietary impacts on mental health.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the ketogenic diet is safe for mental illness?

Research shows that the ketogenic diet, high in fat and low in carbohydrates, is generally easy to follow. Studies have found that this diet can improve metabolic health, which refers to how the body processes food and energy.

Some people report minor side effects, such as fatigue or digestive issues, especially when starting the diet. However, serious side effects are rare. Participants in previous studies have safely followed this diet with medical guidance.

Although the ketogenic diet has been around for a while, its use for mental health conditions remains under study. This study is in a "Not Applicable" phase, indicating that while the diet's safety is somewhat established, more research is needed to understand its impact on mental health. Those considering joining a trial should discuss any potential risks or concerns with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The ketogenic diet is unique because it offers a dietary approach to managing mental illness, which is different from the standard medications like mood stabilizers and antipsychotics. This diet works by significantly reducing carbohydrate intake and increasing fat consumption, leading the body to produce ketones, which may have neuroprotective effects. Researchers are excited because this method could provide an alternative or complementary option for managing mental health conditions, potentially with fewer side effects than traditional medications.

What evidence suggests that the ketogenic diet might be an effective treatment for mental illness?

Research has shown that a ketogenic diet, high in fats and low in carbohydrates, might improve mental health. This diet can reduce symptoms of depression and anxiety by shifting the body's energy source from sugar to ketones, potentially benefiting brain function. One small study found that individuals with severe mental illnesses experienced improvement after following a ketogenic diet focused on whole, unprocessed foods. Another study suggested that this diet could aid those whose conditions do not improve with medication by altering the body's energy use. While more research is needed, these early findings indicate that a ketogenic diet could be a promising approach to managing mental health issues. Participants in this trial will follow the ketogenic diet for 12 weeks, alongside any ongoing medications, to further explore its potential mental health benefits. ^{2 6 7 8 9}

Who Is on the Research Team?

Virginie-Anne Chouinard, MD

Principal Investigator

Mclean Hospital

Are You a Good Fit for This Trial?

This trial is for individuals who have completed the initial 12-week study NCT06221852 and still meet the original criteria. It's aimed at those with conditions like schizoaffective disorder, psychosis, mental illness, or bipolar disorder.

Inclusion Criteria

I completed the 12-week NCT06221852 study and met all its entry requirements.

Exclusion Criteria

No longer meeting original entry criteria from the randomized 12-week study of NCT06221852.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label Extension

Participants follow the ketogenic diet for 12 weeks with diet counseling and daily monitoring of blood ketone and glucose levels

12 weeks

Regular visits for diet counseling and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ketogenic diet

Trial Overview

Participants will continue to follow a ketogenic diet over an additional 12 weeks. This extension of the previous study allows researchers to gather more data on its long-term effects in managing psychiatric disorders.

How Is the Trial Designed?

Group I: Ketogenic diet Experimental Treatment 1 Intervention

Participants will be asked to follow the ketogenic diet (KD) for 12 weeks in addition to any ongoing medications (e.g., mood stabilizers and/or second-generation antipsychotics). Participants will receive diet counseling from a registered dietitian. Participants will be asked to monitor and report their blood ketone and glucose levels each day via a finger-prick device provided by the study team.

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials

221

Recruited

22,500+

Baszucki Family Foundation

Collaborator

Trials

2

Recruited

100+

Published Research Related to This Trial

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]

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 study involving 89 participants with type 2 diabetes, a very low-calorie ketogenic (VLCK) diet led to significantly greater weight loss and improved glycemic control compared to a standard low-calorie diet over 4 months.

The VLCK diet was found to be safe and well-tolerated, with no serious adverse events reported and no significant changes in laboratory safety parameters, indicating it can be a viable option for managing obesity in T2DM patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional weight loss program versus hypocaloric diet in patients with type 2 diabetes mellitus. Goday, A., Bellido, D., Sajoux, I., et al.[2022]

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]

A 4-year-old girl with a rare FBXL4 gene mutation and severe lactic acidosis was successfully treated with a ketogenic diet (KD) after standard treatments failed, highlighting the KD's potential in managing mitochondrial disorders.

This case represents the first documented use of parenteral KD to effectively reduce lactic acidosis in a patient with mitochondrial depletion syndrome, suggesting a promising nonpharmacological intervention for similar conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The first case with FBXL4 mutation successfully treated with a parenteral ketogenic diet for lactic acidosis. İnci, A., Aktaş, E., Cengiz Ergin, FB., 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]

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]

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