Ketogenic Diet for Psychotic Disorders (PsyDiet)
Primary Purpose
Psychosis; Acute, Psychosis, Psychotic Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Ketogenic diet intervention
Sponsored by
About this trial
This is an interventional treatment trial for Psychosis; Acute focused on measuring Ketogenic diet, Intervention, Ketosis, Feasibility, Psychosis, Psychotic symptoms, Schizophrenia, Dietary intervention
Eligibility Criteria
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
Sites / Locations
- Kuopio University Hospital, Department of PsychiatryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Ketogenic diet intervention
Control group
Arm Description
Ketogenic meals will be offered for the participants during the trial.
Conventional hospital meals as usual will be offered during the trial.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
The change in Beck Depression Inventory (BDI) score from baseline to 6 weeks.
Change in depressive symptoms assessed by Beck Depression Inventory scores. BDI is a series of questions developed to measure the intensity, severity, and depth of depression in patients with psychiatric diagnoses. It is composed of 21 questions, each designed to assess a specific symptom. each with four possible responses. Each response is assigned a score ranging from zero to three, indicating the severity of the symptom. Score range is 0-63. Higher values represent a worse outcome.
The change in Beck Anxiety Inventory (BAI) score from baseline to 6 weeks
Change in anxiety symptoms assessed by BAI scores. BAI evaluates both physiological and cognitive symptoms of anxiety and item overlap with other self report depression inventories is minimised. The BAI consists of 21 items; each item is descriptive of a symptom of anxiety and is rated on a scale of 0 to 3. Thus, the score range is from 0 to 63. Higher values represent a worse outcome.
The change in Structured Clinical Interview for DSM Axis I disorders (SCID-I) diagnosis from baseline to 6 weeks
The Structured Clinical Interview for DSM Axis I disorders assessing psychotic symptoms (SCID-I) is a validated semi-structured clinical interview (the gold standard tool for psychiatric assessment in a research setting). SCID-I will be used to assess for past and current psychotic disorders at the beginning and at the 6 week of intervention.
The change in the Global Assessment of Functioning score from baseline to 6 weeks.
Change in The Global Assessment of Functioning (GAF). GAF interview will be conducted at each study time point (baseline, 1, 3 and 6 weeks). GAF scale is used to rate how serious a mental illness may be. It measures how much a person's symptoms affect his or her day-to-day life on a scale of 0 to 100. Higher values represent a worse outcome.
Full Information
NCT ID
NCT03873922
First Posted
August 28, 2018
Last Updated
December 30, 2022
Sponsor
Kuopio University Hospital
Collaborators
Deakin University
1. Study Identification
Unique Protocol Identification Number
NCT03873922
Brief Title
Ketogenic Diet for Psychotic Disorders
Acronym
PsyDiet
Official Title
Dietary Intervention for Psychotic Disorders: a Pilot Intervention Study of Ketogenic Diet for Psychotic Symptoms - PsyDiet Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuopio University Hospital
Collaborators
Deakin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
feasibility of a Modified Ketogenic Diet (MKD) intervention protocol in psychotic inpatients,
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 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.
Detailed 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:
feasibility of a Modified Ketogenic Diet (MKD) intervention protocol in psychotic inpatients,
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis; Acute, Psychosis, Psychotic Disorders, Schizophrenia
Keywords
Ketogenic diet, Intervention, Ketosis, Feasibility, Psychosis, Psychotic symptoms, Schizophrenia, Dietary intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
Blinded research assistant will carry out the PANSS assessment and do the SCID-interviews. Another research assistant will conduct the other measurements (including anthropometry). Care provider will order the meals for the participants, according to the randomization of the patients.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ketogenic diet intervention
Arm Type
Experimental
Arm Description
Ketogenic meals will be offered for the participants during the trial.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Conventional hospital meals as usual will be offered during the trial.
Intervention Type
Other
Intervention Name(s)
Ketogenic diet intervention
Other Intervention Name(s)
KD, Modified Ketogenic Diet
Intervention Description
Ketogenic, really low carbohydrate containing (15-20 g/day), meals will be offered to the participants.
Primary Outcome Measure Information:
Title
The change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to 6 weeks.
Description
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.
Time Frame
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)
Title
Feasibility 1, defined by modified ketogenic diet related experiences, challenges and potential adverse effects during the intervention
Description
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.
Time Frame
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
Title
Feasibility 2, defined by percentage of study participants who discontinue diet and percentage of participants reaching ketosis (measured by blood ketone body levels)
Description
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.
Time Frame
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 Outcome Measure Information:
Title
The change in Beck Depression Inventory (BDI) score from baseline to 6 weeks.
Description
Change in depressive symptoms assessed by Beck Depression Inventory scores. BDI is a series of questions developed to measure the intensity, severity, and depth of depression in patients with psychiatric diagnoses. It is composed of 21 questions, each designed to assess a specific symptom. each with four possible responses. Each response is assigned a score ranging from zero to three, indicating the severity of the symptom. Score range is 0-63. Higher values represent a worse outcome.
Time Frame
Change in BDI score from baseline to 6 weeks OR if discharged earlier, from baseline to the latest study assessment time point (3 weeks)
Title
The change in Beck Anxiety Inventory (BAI) score from baseline to 6 weeks
Description
Change in anxiety symptoms assessed by BAI scores. BAI evaluates both physiological and cognitive symptoms of anxiety and item overlap with other self report depression inventories is minimised. The BAI consists of 21 items; each item is descriptive of a symptom of anxiety and is rated on a scale of 0 to 3. Thus, the score range is from 0 to 63. Higher values represent a worse outcome.
Time Frame
Change in BAI score from baseline to 6 weeks OR if discharged earlier, from baseline to the latest study assessment time point (3 weeks)
Title
The change in Structured Clinical Interview for DSM Axis I disorders (SCID-I) diagnosis from baseline to 6 weeks
Description
The Structured Clinical Interview for DSM Axis I disorders assessing psychotic symptoms (SCID-I) is a validated semi-structured clinical interview (the gold standard tool for psychiatric assessment in a research setting). SCID-I will be used to assess for past and current psychotic disorders at the beginning and at the 6 week of intervention.
Time Frame
Change in SCID-I diagnosis from baseline to 6 weeks
Title
The change in the Global Assessment of Functioning score from baseline to 6 weeks.
Description
Change in The Global Assessment of Functioning (GAF). GAF interview will be conducted at each study time point (baseline, 1, 3 and 6 weeks). GAF scale is used to rate how serious a mental illness may be. It measures how much a person's symptoms affect his or her day-to-day life on a scale of 0 to 100. Higher values represent a worse outcome.
Time Frame
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 Pre-specified Outcome Measures:
Title
Change in Blood lipid levels
Description
Change in measurements of blood lipids (fP-Kol, fP-KOL-LDL, fP-KOL-HDL, fP-Trigly)
Time Frame
Change in blood lipids between baseline and 6 weeks
Title
Change in Fasting glucose levels
Description
Change in measurement of fasting glucose
Time Frame
Change in blood lipids between baseline and 6 weeks
Title
Change in weight/body mass index (BMI) from baseline to 6 weeks
Description
Change in measured weight/BMI
Time Frame
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)
Title
Change in blood pressure (diastolic and systolic) from baseline to 6 weeks.
Description
Change in blood pressure (diastolic and systolic)
Time Frame
Change in blood pressure from baseline to 6 weeks OR if discharged earlier, from baseline to the latest study assessment time point (3 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anu Ruusunen, PhD
Phone
+358407085221
Email
anu.ruusunen@uef.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Felice Jacka, Professor
Email
felicejacka@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anu Ruusunen, PhD
Organizational Affiliation
Kuopio University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio University Hospital, Department of Psychiatry
City
Kuopio
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anu Ruusunen, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Will be decided shortly.
Learn more about this trial
Ketogenic Diet for Psychotic Disorders
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