Ketogenic Diet for Psychotic Disorders
Dietary Intervention for Psychotic Disorders: a Pilot Intervention Study of Ketogenic Diet for Psychotic Symptoms - PsyDiet Pilot Study
Kuopio University Hospital
40 participants
Mar 15, 2021
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
Inclusion Criteria1
- ≥ 18 years old patient with psychotic symptoms / diagnosed psychotic disorder (ICD-10 diagnoses F20-F29)
Exclusion Criteria11
- 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
Interventions
Ketogenic, really low carbohydrate containing (15-20 g/day), meals will be offered to the participants.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03873922