Dietary Intervention for Psychotic Disorders: a Pilot Intervention Study of Ketogenic Diet for Psychotic Symptoms - PsyDiet Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to 6 weeks.
研究概览
简要总结
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 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.
详细描述
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 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old patient with psychotic symptoms / diagnosed psychotic disorder (ICD-10 diagnoses F20-F29)
排除标准
- •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
结局指标
主要结局
The change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to 6 weeks.
时间窗: 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)
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
时间窗: 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 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)
时间窗: 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)
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.
次要结局
- 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 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))
- 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))