Ketogenic Diet for Psychotic Disorders

NCT03873922 | Recruiting

• 1 other identifier: KUH5703458
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 1.feasibility of a Modified Ketogenic Diet (MKD) intervention protocol in psychotic inpatients,
2. 2.potential impact of MKD intervention on psychotic symptoms, depressive and anxiety symptoms, and functioning in patients with psychotic symptoms / psychotic disorder.

Conditions

Psychosis; Acute; Psychosis; Psychotic Disorders; Schizophrenia

Keywords

Ketogenic diet; Intervention; Ketosis; Feasibility; Psychosis; Psychotic symptoms; Schizophrenia; Dietary intervention

Outcome Measures

Primary Outcomes (3)

• The change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to 6 weeks.

  Change in positive and negative psychotic symptoms, assessed at time points baseline, 1, 3 and 6 weeks. The participants are rated from 1 to 7 on 30 different symptoms based on the interview. PANSS Total score minimum is 30, maximum is 210. As 1 rather than 0 is given as the lowest score for each item, a participant can not score lower than 30 for the total PANSS score. Scores are given separately for the positive items, negative items, and general psychopathology scales which altogether (summarized) create a total PANSS score. Higher values represent a worse outcome.

  The change from baseline to the end of the intervention (6 weeks) OR if discharged earlier, from baseline to the latest study assessment time point (1 or 3 weeks)

• Feasibility 1, defined by modified ketogenic diet related experiences, challenges and potential adverse effects during the intervention

  Feasibility will be assessed by modified ketogenic diet related experiences, challenges and potential adverse effects by a Questionnaire of potential side effects and acceptance of MKD during the trial.

  Potential adverse effects during the entire trial will be evaluated (from baseline to 1, 3 and 6 weeks), as observed adverse effects may vary between study time points and status of ketosis

• Feasibility 2, defined by percentage of study participants who discontinue diet and percentage of participants reaching ketosis (measured by blood ketone body levels)

  We will screen blood ketone body levels daily (MKD participants) or weekly (control participants). If participants in the MKD arm are not able to adhere to MKD, they will not reach ketosis or will not stay in ketosis. Feasibility will be defined by percentage of study participants reaching ketosis in the MKD group. In addition, drop-out rate of participants in each study arm will be calculated.

  Percentage of participants reaching ketosis and staying in ketosis in the MKD group will be calculated at each time point (weeks 1, 3 and 6)

Secondary Outcomes (4)

• The change in Beck Depression Inventory (BDI) score from baseline to 6 weeks.

  Change in BDI score from baseline to 6 weeks OR if discharged earlier, from baseline to the latest study assessment time point (3 weeks)

• The change in Beck Anxiety Inventory (BAI) score from baseline to 6 weeks

  Change in BAI score from baseline to 6 weeks OR if discharged earlier, from baseline to the latest study assessment time point (3 weeks)

• The change in Structured Clinical Interview for DSM Axis I disorders (SCID-I) diagnosis from baseline to 6 weeks

  Change in SCID-I diagnosis from baseline to 6 weeks

• The change in the Global Assessment of Functioning score from baseline to 6 weeks.

  Change in GAF score from baseline to 6 weeks OR if discharged earlier, from baseline to the latest study assessment time point (1 or 3 weeks)

Other Outcomes (4)

• Change in Blood lipid levels

  Change in blood lipids between baseline and 6 weeks

• Change in Fasting glucose levels

  Change in blood lipids between baseline and 6 weeks

• Change in weight/body mass index (BMI) from baseline to 6 weeks

  Change in weight/BMI from baseline to 6 weeks OR if discharged earlier, from baseline to the latest study assessment time point (1 or 3 weeks)

Study Arms (2)

Ketogenic diet intervention

EXPERIMENTAL

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

Other: Ketogenic diet intervention

Control group

NO INTERVENTION

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

Interventions

Ketogenic diet intervention OTHER

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

Also known as: KD, Modified Ketogenic Diet

Ketogenic diet intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kuopio University Hospital: lead
• Deakin University: collaborator

Study Sites (1)

Kuopio University Hospital, Department of Psychiatry

Kuopio, Finland

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia; Ketosis

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Anu Ruusunen, PhD

  Kuopio University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anu Ruusunen, PhD

CONTACT

+358503871265; anu.ruusunen@uef.fi

Felice Jacka, Professor

CONTACT

felicejacka@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded research assistant will carry out the PANSS assessment and do the SCID-interviews. Care provider will order the meals for the participants, according to the randomization of the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After baseline examinations, participants will be randomized to receive either ketogenic meals or conventional hospital meals during the study (maximum of six weeks). Otherwise treatment as usual.

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: March 14, 2019
• Study Start: March 15, 2021
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

FI (1)