RecruitingNot ApplicableNCT03873922

Ketogenic Diet for Psychotic Disorders

Dietary Intervention for Psychotic Disorders: a Pilot Intervention Study of Ketogenic Diet for Psychotic Symptoms - PsyDiet Pilot Study


Sponsor

Kuopio University Hospital

Enrollment

40 participants

Start Date

Mar 15, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Disturbances in glucose metabolism and glutamate neurotransmission feature in the pathophysiology of psychotic disorders. Ketogenic diet (KD) is a high-fat, low-carbohydrate diet that restricts glucose and forces metabolism of ketones, which serve as alternative energy substrates for the brain. KD is an established treatment for intractable epilepsy. However, we lack the randomized controlled trials (RCT) evidence regarding potential effects of KD on psychotic symptoms in humans. This randomised, controlled pilot study aims to investigate: 1. feasibility of a Modified Ketogenic Diet (MKD) intervention protocol in psychotic inpatients, 2. potential impact of MKD intervention on psychotic symptoms, depressive and anxiety symptoms, and functioning in patients with psychotic symptoms / psychotic disorder. A 6-week randomised KD pilot study will be carried out in psychotic inpatients (aimed n=40) at Niuvanniemi Hospital and Kuopio University Hospital, Finland. In the KD group, carbohydrate consumption is limited to 15-20 g/day to activate ketosis. The control group will have their ordinary hospital meals. A number of different assessment will be carried out at time points 0, 1 week, 3 weeks and 6 weeks.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether a ketogenic diet — a very high-fat, very low-carbohydrate eating approach — can help reduce symptoms in people with psychotic disorders such as schizophrenia. There is growing research interest in how metabolism and brain chemistry may be connected in psychiatric conditions, and diet may be one way to influence that. **You may be eligible if...** - You are 18 or older - You have been diagnosed with a psychotic disorder such as schizophrenia or a related condition (ICD-10 F20–F29) **You may NOT be eligible if...** - You are underweight (BMI below 18.5) - You have diabetes (with or without insulin) - You are pregnant - You have a current eating disorder - You have inflammatory bowel disease - You have severe alcohol or drug dependence - You have heart failure or rare metabolic disorders - Your psychiatric medications have recently changed - You cannot provide informed consent due to acute symptoms Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERKetogenic diet intervention

Ketogenic, really low carbohydrate containing (15-20 g/day), meals will be offered to the participants.


Locations(1)

Kuopio University Hospital, Department of Psychiatry

Kuopio, Finland

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NCT03873922


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