NCT06335875Completed
Brain Small Chain Fatty Acid Metabolism in Bipolar Disorder: Ketones
Source: ClinicalTrials.gov · Last updated 12 Dec 2025
Brief summary (registry, in English)
Small exploratory open-label pilot study to assess supplementation of a ketone ester (Juvenescence) combined with a 'ketogenic-mimicking diet' as a potential therapy for persons with bipolar disorder.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 21 Mar 2024
- Start date
- 7 Jun 2024
- Primary completion date
- 20 Aug 2025
- Lead sponsor
- University of Michigan
- Diseases
- Bipolar disorder
- NCT number
- NCT06335875
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 7 Jun 2024 to the primary completion date, 20 Aug 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Evidence of large vessel stroke or mass lesion on previous MRI or MRI obtained during study
- Currently receiving treatment with insulin (e.g., chronic pancreatitis, diabetes mellitus)
- 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)
Other illness
- History of moderate-to-severe traumatic brain injury, e.g. loss of consciousness \> 10 min, neurologic sequela
- History of significant GI disease (e.g., malabsorptive disorder, gastric cancer, intestinal resection)
- History of mitochondrial disorder and/or significant uncontrolled metabolic/medical disorder
- Any other condition or criteria that would preclude safe and meaningful participation in this study
Other
- Inability to adhere to dietary changes as specified in protocol (e.g., not in control of food selection)
- 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
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Domino's Farms Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.