COMPLETED

Brain Small Chain Fatty Acid Metabolism in Bipolar Disorder: Ketones

Conditions

Bipolar Disorder ketone ester ketogenic diet brain imaging

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Brain Small Chain Fatty Acid Metabolism in Bipolar Disorder: Ketones

Quick Facts

Study Start:2024-06-07

Study Completion:2025-09-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06335875

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Nicolaas Bohnen, MD

PRINCIPAL_INVESTIGATOR

University of Michigan

Study Locations (Sites)

Domino's Farms

Ann Arbor, Michigan, 48105

United States

University Hospital

Ann Arbor, Michigan, 48109

United States

Collaborators and Investigators

Sponsor: University of Michigan

Nicolaas Bohnen, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-07

Study Completion Date2025-09-03

Study Record Updates

Study Start Date2024-06-07

Study Completion Date2025-09-03

Terms related to this study

Keywords Provided by Researchers

ketone ester
ketogenic diet
brain imaging

Additional Relevant MeSH Terms

Bipolar Disorder