30 Participants Needed

Ketogenic Diet for Bipolar Disorder

KL
Overseen ByKarin Lindstrom, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
Must be taking: Mood stabilizers
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a ketogenic diet, high in fats and low in carbohydrates, might aid individuals with bipolar disorder experiencing depression. Researchers aim to determine if this diet can enhance mood and assess its impact on heart and metabolic health. Suitable candidates for this trial have been diagnosed with bipolar disorder, are experiencing depressive symptoms, and are willing to adopt a ketogenic diet. As an unphased study, this trial provides a unique opportunity to explore potential dietary benefits for mood improvement and overall health.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have stable mood stabilization with certain medications like lithium or atypical antipsychotics, so you might be able to continue those. It's best to discuss your specific medications with the trial team.

What prior data suggests that the ketogenic diet is safe for individuals with bipolar disorder?

Research has shown that the ketogenic diet might be safe for people with bipolar disorder. In one study, most participants who followed the diet entered and stayed in ketosis, where the body uses fat for energy. The side effects were usually mild and manageable. Another study found that people on this diet might feel more satisfied with life and sleep better. Although more research is needed, current evidence suggests that the ketogenic diet could safely help manage symptoms of bipolar disorder.12345

Why are researchers excited about this trial?

Most treatments for bipolar disorder, like mood stabilizers and antipsychotics, focus on balancing neurotransmitters in the brain. The ketogenic diet is unique because it offers a metabolic approach, altering the body's energy source by shifting from carbohydrates to fats. Researchers are excited because this diet might stabilize mood through changes in brain energy metabolism, potentially providing benefits for those who don't respond well to traditional medications. Plus, it offers a non-pharmaceutical option, which could mean fewer side effects compared to conventional treatments.

What evidence suggests that the ketogenic diet might be an effective treatment for bipolar disorder?

Research has shown that a ketogenic diet, which participants in this trial will follow, might help people with bipolar disorder. Some studies suggest that this diet can stabilize the brain by altering its energy use. For instance, a small study found that the keto diet improved severe mental health issues, including bipolar disorder. Another case study reported significant improvement in depression symptoms for someone with bipolar disorder that didn't respond to other treatments. Additionally, higher levels of ketones, produced by this diet, were linked to better mood, increased energy, and reduced anxiety. These findings suggest that a ketogenic diet could be a promising way to manage bipolar symptoms.14567

Who Is on the Research Team?

KM

Kyla M. Lara-Breitinger, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 18-50 with bipolar I or II disorder, or BP schizoaffective Disorder, who are stable medically and willing to switch to a high-fat, low-carb diet. They must not be pregnant, have negative drug screens (except prescribed meds), use birth control if sexually active, and have mild depression at least. Exclusions include severe medical conditions like renal failure, psychosis, substance abuse disorders; current involuntary hospitalization; certain dietary restrictions; and no access to smartphone/internet.

Inclusion Criteria

I am between 18 and 50 years old.
My other health conditions like high blood pressure or diabetes are under control.
I have been diagnosed with bipolar I, II, or schizoaffective disorder.
See 5 more

Exclusion Criteria

I have chronic kidney problems.
Positive toxicology screen for cannabis and cannabis use disorder
I am currently receiving treatments like ECT or transcranial magnetic stimulation.
See 24 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a ketogenic diet to assess clinical and cardiometabolic correlates in bipolar depression

6 months
Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ketogenic Diet
Trial Overview The study tests the effects of a ketogenic diet on individuals with bipolar depression. It aims to understand how this high-fat, low-carbohydrate diet influences mood stability and cardiometabolic health in participants.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Ketogenic DietExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

Pilot study of a ketogenic diet in bipolar disorder - PMCRecent evidence from case reports suggests that a ketogenic diet may be effective for bipolar disorder ... The outcomes data-set was 95% complete for daily ketone ...
Pilot study shows ketogenic diet improves severe mental illnessA small clinical trial led by Stanford Medicine found that the metabolic effects of a ketogenic diet may help stabilize the brain.
NCT06920940 | Child Bipolar Network Ketogenic Diet ...The investigators hypothesize that youth who complied with the 16-week keto diet therapy will show statistically significant reductions in depressive symptoms ...
Retrospective case study: ketogenic metabolic therapy in ...In this case study, a ketogenic diet significantly improved treatment-resistant depressive symptoms in a patient with bipolar disorder. Both ...
Ketogenic Diet Shows Promise for Bipolar DisorderKetogenic Diet Shows Promise for Bipolar Disorder · The team uncovered links between higher ketone levels and improved mood, energy, and anxiety.
Ketogenic Diet Intervention on Metabolic and Psychiatric ...Psychiatric outcomes across the cohort encompassed increased life satisfaction (17 %) and enhanced sleep quality (19 %). This pilot trial underscores the ...
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 ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security