Brain Small Chain Fatty Acid Metabolism in Bipolar Disorder: Ketones

NCT06335875 | Completed

• 1 other identifier: HUM00227568
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Bipolar Disorder

Keywords

ketone ester; ketogenic diet; brain imaging

Outcome Measures

Primary Outcomes (1)

• 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.

  After 90 +/- 10 days of intervention

Secondary Outcomes (2)

• Change in blood glucose lability

  After 90 +/- 10 days of intervention

• Change in neural network stability

  After 90 +/- 10 days of intervention

Study Arms (1)

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.

Dietary Supplement: Ketone Ester Beverage; Behavioral: Low Glycemic Index Diet

Interventions

Low Glycemic Index Diet BEHAVIORAL

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.

Also known as: Ketogenic-mimicking Diet

Bipolar Disorder

Ketone Ester Beverage DIETARY_SUPPLEMENT

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

Also known as: Juvenescence Cognitive Switch™

Bipolar Disorder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (2)

Domino's Farms

Ann Arbor, Michigan, 48105, United States

Location

University Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Nicolaas Bohnen, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: June 7, 2024
• Primary Completion: August 20, 2025
• Study Completion: September 3, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)