An interventional study of Medium chain triglyceride oil in First Episode Psychosis, sponsored by Université de Sherbrooke. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Treatment
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.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 15 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Université de Sherbrooke is the lead sponsor of 295 studies on the registry; 65 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Supplementation with 15 g of medium chain triglyceride oil, emulsified in beverage of choice, twice daily (morning and evening) for 12 weeks,.
Other: Medium chain triglyceride oil
Supplementation with 15 g of medium chain triglyceride oil, a food product commercially available over-the-counter in regular grocery stores, emulsified in beverage of choice, twice daily (morning and evening) for 12 weeks.
Plasma total ketones concentration
Change in plasma total ketone (acetoacetate + betahydroxybutyrate) after 12 weeks of supplementation (uM)
Time frame: 12 weeks
Plasmatic glucose concentration
Change in glucose concentration (mM) after 12 weeks of supplementation (uM)
Time frame: 12 weeks
Plasma Insulin concentraiton
Change in insuline concentration (UI) after 12 weeks of supplementation (uM)
Time frame: 12 weeks
Plasma Glycated hemoglobin
Change in Glycated hemoglobin (%) after 12 weeks of supplementation
Time frame: 12 weeks
acceptability of exogenous ketone supplementation
Participant perspectives will be collected through a short semi-structured interview and analyzed using a descriptive thematic approach.
Time frame: at the end of the 12 weeks treatment
compliance rate
dose of supplement taken during the 12 weeks/ number of dose expected (%)
Time frame: during 12 weeks intervention
Adverse event rate
Total number of adverse event during the intervention
Time frame: 12 weeks intervention
Drop-out rate
Number of participant taht have drop-out/total number of participant included in the study
Time frame: After 12 weeks of intervention
Glucose average (mean of glucose measured by continuous glucose monitoring)
Change in mean plasma glucose concentration (mM) measured by continuous glucose monitoring (CGM) over the course of 8 days; after 12 weeks intervention.
Time frame: 12 weeks
glucose variability (SD of glucose measured by continuous glucose monitoring)
coefficient of variation of plasma glucose concentration (%) measured by systemic glucose metabolism using continuous glucose monitoring (CGM) over the course of 8 days.
Time frame: 12 weeks
Negative symptomes
Change in the score of the Scale for the assessment of negative symptoms (SANS) (score 0 to 125 with worsening of symptom with higher result)
Time frame: 12 weeks
Depression status measured by the score of "Calgary Depression Scale for Schizophrenia
Change int Score of "Calgary Depression Scale for Schizophrenia" (CDSS) . Min score 0, maximum score 27 with worsening of the patient condition with hight value
Time frame: 12 weeks
Brief Assessment of Cognition (BACS)
Change in composite score (express as Z score) of the brief assessment of cogition
Time frame: 12 weeks
Functionning level measured by the score of the Global Assessment of functionning
Change in the Score of the "Global Assessment of functionning (GAF). Min score 0, maximum score 100, with worsening of the patient condition with higher value
Time frame: 12 weeks
Plan to share: No
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