The effects of ketogenic metabolic therapy on mental health and metabolic outcomes in schizophrenia and bipolar disorder: a randomized controlled clinical trial protocol.
Level 5 - mechanism / opinion, no new human data
Trial protocol describing planned methodology without human outcome data
PubMed 39234289 · doi:10.3389/fnut.2024.1444483
What was done
This publication presents the study protocol for a 14-week randomized controlled clinical trial of 100 non-hospitalized adult participants with schizophrenia, schizoaffective disorder, or bipolar disorder. The intervention is a dietitian-led, medically supervised modified ketogenic diet compared against a control diet adhering to the Australian Guide to Healthy Eating. Planned primary outcomes encompass psychiatric and cognitive measures (PANSS, Young Mania Rating Scale, Beck Depression Inventory, WHO Disability Schedule, Affect Lability Scale, Cambridge Cognitive Battery). Planned secondary endpoints include metabolic indices (weight, blood pressure, lipids, insulin resistance, hepatic and renal function), wearable device biometrics, and optional hair cortisol and microbiome analyses.
What was found
No clinical results or statistical findings are reported; the publication describes only the trial protocol and expected hypotheses.
Why it matters
If executed, this trial will provide controlled experimental evidence on whether metabolic intervention via nutritional ketosis improves cognitive, psychiatric, and metabolic profiles in patients with serious mental illness.
Limits
As a protocol paper, no empirical outcome data are available. The design is restricted to stable, non-hospitalized community patients willing and able to adopt substantial dietary changes, which may limit generalizability to more acutely ill cohorts.
Cited by
- supports Ketogenic diets are being clinically investigated and used as metabolic therapies for severe mental illnesses including schizophrenia and bipolar disorder.