Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335875
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-03-21
Brief Title:
Brain Small Chain Fatty Acid Metabolism in Bipolar Disorder Ketones
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Brain Small Chain Fatty Acid Metabolism in Bipolar Disorder Ketones
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIPO
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
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 glycemicinsulin 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None