Baszucki Group announced a £1.17 million grant to support a randomized controlled trial at the University of Oxford evaluating the feasibility, safety, and efficacy of ketogenic therapy for patients at clinical high risk of psychosis (CHR-P). The study will examine whether a modified ketogenic diet can improve both mental and physical health outcomes for patients experiencing early symptoms associated with psychotic disorders.
The trial will enroll 50 CHR-P patients between the ages of 14 and 35, randomly assigning participants to either a 12-week modified ketogenic diet or a control diet. Researchers will monitor symptom severity throughout the study using the Comprehensive Assessment of At-Risk Mental States (CAARMS) assessment tool, which is specifically designed to evaluate young people at elevated risk of developing psychosis.
Participants will receive support from registered dietitians and will use glucose and ketone monitoring kits to track adherence to the ketogenic therapy. Researchers will also evaluate cognitive function, sleep behavior, physical health, and overall symptom progression. In addition, the study will follow participants for up to three years after the intervention using electronic health records to assess long-term outcomes.
The research project builds on increasing scientific interest in metabolic therapies as potential treatments for serious mental illness. According to the announcement, psychosis often emerges after a period of subtle, early symptoms, creating an opportunity for preventative intervention before full psychotic onset occurs. Current treatment options for CHR-P patients remain limited, and there is currently no indicated treatment specifically designed to reduce the transition rate to full psychosis.
The trial will also provide researchers with an opportunity to study the biological mechanisms associated with both psychosis and ketogenic therapy. Since many CHR-P patients are not prescribed antipsychotic medications, investigators believe the study may help isolate the effects of ketogenic therapy as a stand-alone treatment. In a subgroup of participants, researchers will directly measure brain energy metabolism through blood biomarkers and neuroimaging.
Baszucki Group said the project aligns with its broader focus on advancing research at the intersection of metabolism, psychiatry, and neuroscience. The organization was launched in 2021 by David Baszucki and Jan Ellison Baszucki.
KEY QUOTES:
“We see promise in ketogenic therapy as a non-stigmatizing, accessible intervention for those navigating early signs of psychosis. If effective, the diet could represent a novel tool that will allow us to intervene before psychotic onset. We are hopeful that by studying the critical window that often precedes psychotic onset, we can change the long-term trajectory of mental well-being in our patients.”
Amedeo Minichino, Associate Professor, Honorary Consultant Psychiatrist, and Wellcome Trust Early Career Fellow, University of Oxford
“This study is an important step forward in understanding the potential of ketogenic therapy on physical and mental health in this highly vulnerable patient group. This ambitious project represents a rare opportunity to gain a deeper understanding of how ketogenic therapy could fundamentally transform the trajectory of serious mental illness in a largely medication-naive population. We are thrilled to support the research team at Oxford in this first-of-its-kind trial.”
Jan Ellison Baszucki, Co-founder and President, Baszucki Group
