Ketogenic Diet for Psychotic Disorders (PsyDiet)

Kuopio University Hospital

Status: Enrolling

Conditions: Psychotic Disorders; Psychosis; Acute; Schizophrenia; Psychosis

Treatments: Other: Ketogenic diet intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03873922

KUH5703458

Details and patient eligibility

About

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.

Full description

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 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. The Structured Clinical Interview for DSM Axis I disorders (SCID-I), and the Positive and Negative Syndrome Scale (PANSS) will assess current psychotic disorders and psychotic symptoms, respectively. Blood glucose, lipid, and ketone body levels, and weight will be measured. Background variables (socioeconomic factors, comorbidities, obtained treatments including medications, and health behaviours including diet) will be documented.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Ketogenic diet intervention

Experimental group

Description:

Ketogenic meals will be offered for the participants during the trial.

Treatment:

Other: Ketogenic diet intervention

Control group

No Intervention group

Description:

Conventional hospital meals as usual will be offered during the trial.