NCT06081426

Examining Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD)

Elucidating Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD): a Multidisciplinary Mechanistic Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The investigators aim to examine the effect of the ketogenic diet on brain activity, metabolism, and emotions in adults with Bipolar Disorder (BD).

Detailed description

The investigators hypothesize that a ketogenic diet will enhance levels of the ketone body β-Hydroxybutyrate (beta OHB), resulting in reduced mania/hypomania severity and predisposition to mania/hypomania in individuals with BD. To test this hypothesis in depth, the investigators will use a novel, multidisciplinary mechanistic study using multimodal neuroimaging, peripheral markers of mitochondrial metabolism, and participant-derived induced pluripotent stem cell (iPSC)-derived organoids.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
OTHER	Non-ketogenic Diet	Consuming a non-ketogenic diet
OTHER	Ketogenic Diet	Consuming a ketogenic diet
OTHER	No diet	Participants without Bipolar Disorder will not participate in the diet phases of the study

Timeline

• Start date: 2024-01-12
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2023-10-13
• Last updated: 2025-12-10

Locations

1 site across 1 country: United States