Ketogenic Diet Intervention on Metabolic and Psychiatric Health in Bipolar and Schizophrenia: A Pilot Trial.
Level 4 - case-series / case-control
Single-arm uncontrolled intervention trial (case-series design)
PubMed 38547601 · doi:10.1016/j.psychres.2024.115866
What was done
A 4-month prospective, single-arm pilot trial evaluated the effects of an adjunctive ketogenic diet intervention in 23 participants with schizophrenia or bipolar disorder who had pre-existing metabolic abnormalities.
What was found
By study conclusion, 0 participants met metabolic syndrome criteria. Adherent individuals experienced a 12% reduction in weight, a 12% reduction in BMI, a 13% reduction in waist circumference, and a 36% reduction in visceral adipose tissue. Biomarker improvements included a 27% decrease in HOMA-IR and a 25% drop in triglyceride levels. In participants with schizophrenia, Brief Psychiatric Rating Scale scores decreased by 32%. Clinical Global Impression (CGI) severity improved by an average of 31%, and 79% of participants starting with elevated symptomatology improved by at least 1 point on CGI. Across the full cohort, life satisfaction increased by 17% and sleep quality improved by 19%.
Why it matters
This study provides preliminary pilot data suggesting that ketogenic metabolic therapy may concurrently improve metabolic dysfunction and psychiatric symptomatology in serious mental illness.
Limits
The study is limited by a small sample size (n=23), a single-arm design without a control or sham group, and lack of blinding, leaving findings vulnerable to placebo effects and confounding. Some reported outcomes were restricted to adherent participants rather than an intention-to-treat analysis.
Cited by
- supports Ketogenic diets are being clinically investigated and used as metabolic therapies for severe mental illnesses including schizophrenia and bipolar disorder.