Randomized Controlled Trial of Ketogenic and Nutritional Diets for Brain Energy and Psychiatric Symptoms in First Episode Bipolar Disorder

What this Trial Is About

Researchers are evaluating the effects of a ketogenic diet combined with usual treatment on brain energy metabolism and psychiatric symptoms in individuals experiencing their first episode of bipolar disorder or schizoaffective disorder. This randomized, controlled clinical trial aims to use advanced imaging and metabolic measures to study how nutritional ketosis influences brain energy and mood symptoms over 12 weeks. Participants will be randomly assigned to either follow a ketogenic diet or the Dietary Guidelines for Americans diet, both alongside their current medications such as mood stabilizers or antipsychotics. The ketogenic diet emphasizes high fat, low carbohydrate, and adequate protein intake, while the comparison diet focuses on nutrient-dense foods with limited added sugars and saturated fat. Weekly diet counseling and daily blood ketone monitoring via finger-prick devices are part of the study. After the initial 12 weeks, participants may opt into an additional 12-week open-label phase continuing the ketogenic diet. Throughout the study, participants will undergo brain imaging and metabolic assessments to measure changes in brain energy markers like NAD+/NADH ratio and creatine kinase activity, along with evaluations of psychotic, depressive, and manic symptoms. Researchers will also track insulin resistance, body weight, blood lipids, inflammatory markers, and cognitive and functional outcomes. Safety and symptom changes will be monitored over the 12-week period, with further data collected if the optional extension phase is chosen.

Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder