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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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
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.
Domino's Farms
Ann Arbor, Michigan, United States
University Hospital
Ann Arbor, Michigan, United States
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.
Time frame: After 90 +/- 10 days of intervention
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.
Time frame: 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.
Time frame: After 90 +/- 10 days of intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.