Bipolar DisorderBIPONCT06335875
Brain Small Chain Fatty Acid Metabolism in Bipolar Disorder: Ketones
A study testing Ketone Ester Beverage and Low Glycemic Index Diet in people with Bipolar Disorder, run by University of Michigan at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Ketone Ester Beverage and Low Glycemic Index Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jun 2024to 3 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Domino's Farms
Ann Arbor, Michigan, 48105
University Hospital
Ann Arbor, Michigan, 48109
About this study
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.
Read the detailed description
The overarching goal of this open-label, exploratory pilot study is to explore biomechanistic effects of exogenous ketone supplementation combined with a low glycemic diet (in effect, a 'ketogenic-mimicking diet') for patients with bipolar disorder. This represents a less restrictive metabolic intervention compared to a strict ketogenic diet while replicating two foundational elements of the ketogenic diet: low levels of glycemic/insulin signaling and high levels of circulating ketones. In addition to assessments of mood stability and global functioning, functional neuroimaging data will be obtained to better characterize the biomechanistic effects of this intervention.
- Conditions
- Bipolar Disorder
- Being tested
- Ketone Ester Beverage, Low Glycemic Index Diet
- Keywords
- ketone ester, ketogenic diet, brain imaging
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone Ester BeverageDietary supplement
Also called Juvenescence Cognitive Switch™
Participants will consume ketone ester (KE) beverage, consisting of 19 g (=12.5 g active C8-KE) of Juvenescence Cognitive Switch™ diluted in water, twice per day
Low Glycemic Index DietBehavioural
Also called Ketogenic-mimicking Diet
Participants will practice four dietary changes: 1. Not consuming sweets/candy, 2. Not consuming soda, 3. Replacing 'white' grains with complex carbohydrates such as brown rice or quinoa, and 4. Reserving any fruit consumption for the end of meals.
| Study group | Role | What they receive |
|---|---|---|
| Bipolar Disorder | Experimental | Participants will follow an intervention consisting of dietary changes and ketone ester supplementation for 90 +/- 10 days. The dietary changes are intended to reduce glycemic spiking and include: not consuming sweets, not consuming soda, replacing 'white' grains with whole grain alternatives, and reserving any fruit consumption for the end of meals. During the same time period, participants will consume the ketone ester supplement, consisting of 19 g Juvenescence Cognitive Switch™ (=12.5 g active C8-KE) diluted in water twice per day. Receives: Dietary Supplement: Ketone Ester Beverage; Behavioral: Low Glycemic Index Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood beta-hydroxybutyrate level
Keto-Mojo devices will be used to measure blood beta-hydroxybutyrate levels at baseline and after taking the supplement to assess both immediate and sustained effects on blood beta-hydroxybutyrate. Measurements taken at baseline, mid-intervention, and post-intervention will be compared and regressed to analyze associated changes.
Measured: After 90 +/- 10 days of intervention
Secondary outcomes (2)
Change in blood glucose lability
Continuous glucose monitoring (CGM) devices will be used to capture blood glucose lability, defined as frequency of glycemic spiking averaged per day. Baseline blood glucose lability and post-intervention blood glucose lability will be compared to analyze associated changes.
Measured: After 90 +/- 10 days of intervention
Change in neural network stability
Functional Magnetic Resonance Imaging (fMRI) will be used to measure neural network stability (defined by correlations and anticorrelations among brain regions over time. Computed neural network stability after the supplementation/dietary change period will be compared to computed neural network stability at baseline.
Measured: After 90 +/- 10 days of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start7 Jun 2024
- Primary completion20 Aug 2025
- Study completion3 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolaas Bohnen, MD, PhD, University of Michigan
- Investigators
- Nicolaas Bohnen, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335875
- Sponsor's protocol ID
- HUM00227568
- Acronym
- BIPO
- Status last verified
- Dec 2025
- First submitted
- 21 Mar 2024
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Small Chain Fatty Acid Metabolism in Bipolar Disorder: Ketones
- ClinicalTrials.gov ID
- NCT06335875
- Acronym / sponsor ID
- BIPO / HUM00227568
- Conditions
- Bipolar Disorder
- Keywords
- ketone ester, ketogenic diet, brain imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overarching goal of this open-label, exploratory pilot study is to explore biomechanistic effects of exogenous ketone supplementation combined with a low glycemic diet (in effect, a 'ketogenic-mimicking diet') for patients with bipolar disorder. This represents a less restrictive metabolic intervention compared to a strict ketogenic diet while replicating two foundational elements of the ketogenic diet: low levels of glycemic/insulin signaling and high levels of circulating ketones. In addition to assessments of mood stability and global functioning, functional neuroimaging data will be obtained to better characterize the biomechanistic effects of this intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bipolar Disorder | Experimental | Dietary Supplement: Ketone Ester Beverage, Behavioral: Low Glycemic Index DietParticipants will follow an intervention consisting of dietary changes and ketone ester supplementation for 90 +/- 10 days. The dietary changes are intended to reduce glycemic spiking and include: not consuming sweets, not consuming soda, replacing 'white' grains with whole grain alternatives, and reserving any fruit consumption for the end of meals. During the same time period, participants will consume the ketone ester supplement, consisting of 19 g Juvenescence Cognitive Switch™ (=12.5 g active C8-KE) diluted in water twice per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketone Ester BeverageAlso: Juvenescence Cognitive Switch™Participants will consume ketone ester (KE) beverage, consisting of 19 g (=12.5 g active C8-KE) of Juvenescence Cognitive Switch™ diluted in water, twice per day | Dietary supplement | Bipolar Disorder |
| Low Glycemic Index DietAlso: Ketogenic-mimicking DietParticipants will practice four dietary changes: 1. Not consuming sweets/candy, 2. Not consuming soda, 3. Replacing 'white' grains with complex carbohydrates such as brown rice or quinoa, and 4. Reserving any fruit consumption for the end of meals. | Behavioural | Bipolar Disorder |
Primary outcome
Change in blood beta-hydroxybutyrate level
Time frame: After 90 +/- 10 days of intervention
Keto-Mojo devices will be used to measure blood beta-hydroxybutyrate levels at baseline and after taking the supplement to assess both immediate and sustained effects on blood beta-hydroxybutyrate. Measurements taken at baseline, mid-intervention, and post-intervention will be compared and regressed to analyze associated changes.
2 secondary outcomes
Change in blood glucose lability
Time frame: After 90 +/- 10 days of intervention
Change in neural network stability
Time frame: After 90 +/- 10 days of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolaas Bohnen, MD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketone Ester Beverage and Low Glycemic Index Diet in people with Bipolar Disorder, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood beta-hydroxybutyrate level (time frame: After 90 +/- 10 days of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.