Using a Ketogenic Diet to Treat Psychotic Disorders
Dietary Intervention for Psychotic Disorders: a Pilot Intervention Study of Ketogenic Diet for Psychotic Symptoms - PsyDiet Pilot Study
This study is testing if a special low-carb diet can help improve symptoms in people with psychotic disorders who are in the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kuopio University Hospital Academic / other |
| Locations | 1 site (Kuopio) |
| Trial ID | NCT03873922 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the feasibility and effects of a Modified Ketogenic Diet (MKD) on psychotic symptoms in hospitalized patients diagnosed with psychotic disorders. The study will randomly assign participants to either a ketogenic diet group, where carbohydrate intake is limited to 15-20 g/day, or a control group receiving standard hospital meals. Over six weeks, researchers will assess changes in psychotic symptoms, depressive and anxiety symptoms, and overall functioning using structured clinical interviews and symptom scales. Blood glucose, lipid levels, and ketone bodies will also be monitored to evaluate metabolic changes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with diagnosed psychotic disorders exhibiting psychotic symptoms.
Not a fit: Patients with certain medical conditions, such as diabetes, severe eating disorders, or acute medical issues, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel dietary intervention for managing psychotic symptoms in patients.
How similar studies have performed: While ketogenic diets have been established for epilepsy treatment, this specific application for psychotic disorders is novel and lacks extensive prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 18 years old patient with psychotic symptoms / diagnosed psychotic disorder (ICD-10 diagnoses F20-F29) Exclusion Criteria: * BMI \<18.5 * Diabetes mellitus (with or without insulin treatment) * Inability to provide informed consent or to participate due to acute medical conditions, such as severe and acute psychotic symptoms or acute suicidality * Impairments in vision, audition or immobility * Pregnancy * Diagnosed current eating disorder * Diagnosed Inflammatory Bowel Disease (IBD) * Severe alcohol or substance abuse * Decompensated cardial insufficiency * Infrequent/rare metabolic disorders, such as porphyria, disturbances in fatty acid oxidation or deficiency of CTT1, CPTII, carnitine or pyruvate carboxylase * changes have occurred in psychotropic medications during the last 4 weeks
Where this trial is running
Kuopio
- Kuopio University Hospital, Department of Psychiatry — Kuopio, Finland (Recruiting)
Study contacts
- Principal investigator: Anu Ruusunen, PhD — Kuopio University Hospital
- Study coordinator: Anu Ruusunen, PhD
- Email: anu.ruusunen@uef.fi
- Phone: +358503871265
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.