Exploring ketone supplementation and diet for bipolar disorder
Brain Small Chain Fatty Acid Metabolism in Bipolar Disorder: Ketones
This study is testing if a ketone supplement combined with a low-sugar diet can help improve mood and daily functioning in adults with bipolar disorder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 2 sites (Ann Arbor, Michigan and 1 other locations) |
| Trial ID | NCT06335875 on ClinicalTrials.gov |
What this trial studies
This exploratory pilot study investigates the effects of a ketone ester supplement combined with a low glycemic index diet on individuals with bipolar disorder. The approach aims to replicate key elements of a ketogenic diet while being less restrictive. Participants will undergo assessments of mood stability and global functioning, alongside functional neuroimaging to understand the biomechanistic impacts of the intervention. The study focuses on individuals aged 18 and older who can provide informed consent and have a stable psychiatric medication regimen.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with bipolar disorder who can adhere to dietary changes.
Not a fit: Patients with significant gastrointestinal diseases or those unable to follow dietary protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could offer a novel dietary approach to improve mood stability in patients with bipolar disorder.
How similar studies have performed: While this approach is exploratory, similar dietary interventions have shown promise in managing mood disorders, though this specific combination is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 and older * Able to provide informed consent * Diagnosis of bipolar disorder, type I or II as determined primarily via medical/psychiatric documentation provided from mental health provider with patient consent * Regular access to smart phone capable of syncing biometric wearable data collection * If taking psychiatric medications, on stable regimen as defined by no medication changes for mood stabilizers and/or antipsychotics in prior 4 weeks Exclusion Criteria: * Inability to adhere to dietary changes as specified in protocol (e.g., not in control of food selection) * History of moderate-to-severe traumatic brain injury, e.g. loss of consciousness \> 10 min, neurologic sequela * Evidence of large vessel stroke or mass lesion on previous MRI or MRI obtained during study * History of significant GI disease (e.g., malabsorptive disorder, gastric cancer, intestinal resection) * Pregnancy (as determined via urine pregnancy test at study initiation), if capable of becoming pregnant, or breastfeeding * Unwilling to utilize birth control method during course of study (e.g., barrier contraception, oral contraceptive, IUD), if capable of becoming pregnant * Currently receiving treatment with insulin (e.g., chronic pancreatitis, diabetes mellitus) * History of mitochondrial disorder and/or significant uncontrolled metabolic/medical disorder * Active/current illicit substance use (and/or consumption of \>1 alcoholic beverages per day) - defined as using psychoactive medications not as prescribed or using illicit substances (as determined via urine drug screen and screening interview) * Use of marijuana or THC products more than once monthly on average * Subjects with contra-indications to MR imaging, including pacemakers or severe claustrophobia, and/or size incompatible with scanner gantry, e. g., men over 6 feet tall that weigh more than 250 lbs, men under 6 feet tall that weigh over 220 lbs, women over 5'11" tall that weigh more than 220 lbs, or women under 5'10" tall that weigh more than 200 lbs. Subjects of these weights or greater typically have difficult fitting into the fMRI scanner properly. * Suicidal thoughts with plans or intentions, as assessed by C-SSRS * Any other condition or criteria that would preclude safe and meaningful participation in this study
Where this trial is running
Ann Arbor, Michigan and 1 other locations
- Domino's Farms — Ann Arbor, Michigan, United States (Recruiting)
- University Hospital — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Nicolaas Bohnen, MD — University of Michigan
- Study coordinator: Rob Vangel, BSc
- Email: rvangel@med.umich.edu
- Phone: 734-936-1168
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.