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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥ 18 years old patient with psychotic symptoms / diagnosed psychotic disorder (ICD-10 diagnoses F20-F29)

Locations
Other Locations
Finland
Kuopio University Hospital, Department of Psychiatry
RECRUITING
Kuopio
Contact Information
Primary
Anu Ruusunen, PhD
anu.ruusunen@uef.fi
+358503871265
Backup
Felice Jacka, Professor
felicejacka@gmail.com
Time Frame
Start Date: 2021-03-15
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 40
Treatments
Experimental: Ketogenic diet intervention
Ketogenic meals will be offered for the participants during the trial.
No_intervention: Control group
Conventional hospital meals as usual will be offered during the trial.
Related Therapeutic Areas
Sponsors
Collaborators: Deakin University
Leads: Kuopio University Hospital

This content was sourced from clinicaltrials.gov