Ketogenic Diet for Mental Health

(LIVE IT~LAUNCH Trial)

Overseen By Ann Kearns, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Ketogenic diet experience, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to teach participants how to start and maintain a ketogenic diet, a low-carb, high-fat eating plan, to improve mental health. Participants will first attend a mastery class to learn about the diet and have their questions answered. They will then follow the diet for four weeks, with optional private and group consultations. This trial is ideal for clinicians, researchers, or team members who want to learn and apply the ketogenic diet without prior experience. As an unphased trial, it offers a unique opportunity for participants to gain firsthand experience and knowledge about the ketogenic diet's potential mental health benefits.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial organizers or your doctor.

What prior data suggests that this ketogenic diet program is safe for mental health?

Research has examined the ketogenic diet's effects on mental health. One study showed that after four months on this diet, most participants experienced significant improvement in their mental health symptoms, suggesting potential benefits for mental health issues.

Another study highlighted that the ketogenic diet could complement treatments for serious mental illnesses. These studies assessed both the benefits and safety of the diet. Generally, participants tolerated the diet well, with no major safety concerns identified.

Overall, the ketogenic diet appears promising for mental health support and is safe for most people. However, individual results may vary. Consulting a healthcare provider before starting any new diet or treatment is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for mental health, which often involves medications and therapy, the Medical Keto Education Program offers a unique approach by using dietary changes to potentially influence mental health. Researchers are excited about this treatment because it applies the ketogenic diet, known for its effects on brain metabolism, to mental health. This diet alters the body's energy source from glucose to ketones, which might help stabilize mood and cognitive function. By exploring this nutritional strategy, the program could provide a new, non-pharmaceutical option for individuals seeking alternative or complementary mental health treatments.

What evidence suggests that the Medical Keto Education Program is effective for mental health?

Research has shown that the ketogenic diet, high in fats and low in carbohydrates, can help reduce symptoms of mental health issues. Studies have found that, on average, the severity of mental illness improved by 31% when people followed this diet. Many individuals notice significant improvements in their mental health symptoms after adhering to this diet for four months. It has also shown promise as a helpful addition to treatments for conditions like bipolar disorder. Overall, the ketogenic diet appears to be a beneficial approach for improving mental health. Participants in this trial will engage in the Medical Keto Mastery Class to explore these potential benefits. ^{1 2 3 4 5}

Who Is on the Research Team?

Deanna L Kelly, PharmD, BCPP

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

This trial is for individuals interested in learning how to implement a ketogenic diet with the aim of improving mental health. Participants should be willing to engage in an educational program and follow a ketogenic diet for 4 weeks.

Inclusion Criteria

I am between 18 and 74 years old.

Clinician, researcher or clinical or research team member

Not currently on a ketogenic diet

Exclusion Criteria

I am between 18 and 74 years old.

Body mass index > 18.5

Not currently on a ketogenic diet (Self report)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Mastery Class

Participants attend a 4-hour mastery class and two 1.5-hour Q&A sessions to learn about the ketogenic diet

1 week

1 visit (in-person or virtual)

Preparation

Participants complete dietician meetings and prepare for the ketogenic diet

2 weeks

Open Label LIVE IT Ketogenic Diet

Participants self-implement a medical ketogenic diet with private and group consultation

4 weeks

Group and private consultations

Follow-up

Participants are monitored for competence in implementing the diet and improvements in physical and mental health

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Medical Keto Education Program

Trial Overview The intervention being tested is a 'train the trainer' style education program on medical ketogenic diets, which includes mastery classes and optional private/group consultations during a 4-week period of self-implemented diet adherence.

How Is the Trial Designed?

Group I: Medical Keto Mastery Class Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8120987/

The use of the ketogenic diet in the treatment of psychiatric ... The studies included in this review indicated the KD was beneficial in reducing symptoms associated with various psychiatric disorders.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0165178124001513

Ketogenic Diet Intervention on Metabolic and Psychiatric ... The psychiatric outcomes indicate that, on average, the severity of mental illness, as assessed by the Clinical Global Impressions scale, improved by 31 %.

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. clinicaltrials.gov clinicaltrials.gov/study/NCT07116226

Learning How to Implement and Use a Ketogenic Diet ... Learning How to Implement and Use a Ketogenic Diet to Improve Mental Health. Conditions. Medical Keto Diet. Medical Keto Diet. Medical Keto Diet.

5. nature.com nature.com/articles/s41398-025-03544-8

A pilot study examining a ketogenic diet as an adjunct ... A ketogenic diet (KD) has shown promise as an adjunctive therapy for neurological and neuropsychiatric disorders, including bipolar disorder ...