Metabolic and Clinical Evaluation of Medium-Chain Triglyceride-Based Exogenous Ketone Supplementation as an Adjunctive Treatment for First-Episode Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Plasma total ketones concentration
研究概览
简要总结
The RECAP project will evaluate the clinical and metabolic effects of adding exogenous ketones to antipsychotic (AP) treatment in young adults with a first episode of psychosis (FEP).
FEP requires early intervention to limit relapse, chronic symptoms, cognitive decline, and reduced life expectancy. Symptoms include positive (hallucinations, delusions), negative (amotivation, anhedonia), cognitive (attention, working memory), and mood disturbances. Standard care combines second- or third-generation APs with psychosocial interventions. However, many patients have persistent symptoms despite optimal treatment.
Psychosis is linked to increased cardiovascular and obesity risk. APs can cause insulin resistance, type 2 diabetes, and dyslipidemia, but some metabolic abnormalities-both systemic and cerebral-may precede AP use, suggesting an intrinsic metabolic dysfunction. Brain energy metabolism is often impaired, with altered insulin signaling, glucose transport, and ATP production. Glucose hypometabolism in the prefrontal cortex correlates with negative and cognitive symptoms, even before medication, resembling patterns in Alzheimer's, bipolar disorder, and depression.
Ketones, especially beta-hydroxybutyrate, provide an alternative to glucose for brain energy. Ketogenic diets have therapeutic potential but are difficult to maintain, particularly in psychiatric populations. Exogenous ketones, such as medium-chain triglycerides (MCTs), can raise circulating ketone levels without major dietary changes. MCT supplementation has been shown to improve brain metabolism and cognition in other conditions, but no studies have tested it in FEP.
This uncontrolled, prospective pilot study will provide 15 g of MCT oil twice daily for 12 weeks, in addition to participants' usual diet and treatment. The primary objective is to assess changes in circulating ketone levels and metabolic markers (glucose, insulin, HbA1c). Secondary objectives include feasibility, acceptability, effects on real-time glucose metabolism (via continuous glucose monitoring), clinical symptoms (negative, cognitive), quality of life, other metabolic biomarkers, and general systemic markers.
This is the first study to test exogenous ketones in FEP. It will assess safety, tolerability, and potential metabolic and clinical benefits, offering preliminary mechanistic insights and guiding future integrative mental health strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred or self-referred to the PEP Clinic of the Estrie region, either as an outpatient or inpatient.
- •Currently receiving a second- or third-generation antipsychotic at a stable dose for at least 4 weeks.
- •Able to read and communicate in French or English.
- •Capable of understanding and signing the informed consent form.
排除标准
- •Pregnancy, childbirth within the past 6 months, or breastfeeding.
- •any use of MCT oil, ketone salts, or a ketogenic diet within the past year.
- •Previous diagnosis of type I or type II diabetes.
- •Uncontrolled acute suicidal ideation at the time of inclusion in the PEP clinic.
- •Other conditions that may interfere with participation, as determined by the qualified physician.
- •Pancreatitis (inflammation of the pancreas) or liver failure.
- •Metabolic condition affecting fat metabolism or inherited carnitine deficiency and its related enzymes.
- •Porphyria.
- •Pyruvate kinase deficiency.
- •Neurodevelopmental disorder of unknown etiology or rare genetic disease.
研究组 & 干预措施
12 week ketogenic supplementation
Supplementation with 15 g of medium chain triglyceride oil, emulsified in beverage of choice, twice daily (morning and evening) for 12 weeks,.
干预措施: Medium chain triglyceride oil (Other)
结局指标
主要结局
Plasma total ketones concentration
时间窗: 12 weeks
Change in plasma total ketone (acetoacetate + betahydroxybutyrate) after 12 weeks of supplementation (uM)
Plasmatic glucose concentration
时间窗: 12 weeks
Change in glucose concentration (mM) after 12 weeks of supplementation (uM)
Plasma Insulin concentraiton
时间窗: 12 weeks
Change in insuline concentration (UI) after 12 weeks of supplementation (uM)
Plasma Glycated hemoglobin
时间窗: 12 weeks
Change in Glycated hemoglobin (%) after 12 weeks of supplementation
次要结局
- acceptability of exogenous ketone supplementation(at the end of the 12 weeks treatment)
- Depression status measured by the score of "Calgary Depression Scale for Schizophrenia(12 weeks)
- Adverse event rate(12 weeks intervention)
- compliance rate(during 12 weeks intervention)
- Drop-out rate(After 12 weeks of intervention)
- Glucose average (mean of glucose measured by continuous glucose monitoring)(12 weeks)
- glucose variability (SD of glucose measured by continuous glucose monitoring)(12 weeks)
- Negative symptomes(12 weeks)
- Brief Assessment of Cognition (BACS)(12 weeks)
- Functionning level measured by the score of the Global Assessment of functionning(12 weeks)
研究者
Stephen Cunnane
Professor
Université de Sherbrooke