Hotel-Dieu CIUSSS de l'Estrie-CHUS
Sherbrooke, Quebec, J1H 4C4, Canada
Location status: Recruiting
Location contact
Kevin Zemmour, MD
PRINCIPAL_INVESTIGATOR
Melanie Fortier, MSc
CONTACT
NCT Number: NCT07122531
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.
Interested in participating?
Request Info18 year–35 year
All sexes
Interventional
Not applicable
Sherbrooke, Quebec, J1H 4C4, Canada
Location status: Recruiting
Kevin Zemmour, MD
PRINCIPAL_INVESTIGATOR
Melanie Fortier, MSc
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 12 weeks
Change in plasma total ketone (acetoacetate + betahydroxybutyrate) after 12 weeks of supplementation (uM)
Time frame: 12 weeks
Change in glucose concentration (mM) after 12 weeks of supplementation (uM)
Time frame: 12 weeks
Change in insuline concentration (UI) after 12 weeks of supplementation (uM)
Time frame: 12 weeks
Change in Glycated hemoglobin (%) after 12 weeks of supplementation
Time frame: at the end of the 12 weeks treatment
Participant perspectives will be collected through a short semi-structured interview and analyzed using a descriptive thematic approach.
Time frame: during 12 weeks intervention
dose of supplement taken during the 12 weeks/ number of dose expected (%)
Time frame: 12 weeks intervention
Total number of adverse event during the intervention
Time frame: After 12 weeks of intervention
Number of participant taht have drop-out/total number of participant included in the study
Time frame: 12 weeks
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
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
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
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
Change in composite score (express as Z score) of the brief assessment of cogition
Time frame: 12 weeks
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
Contact information is provided by the study sponsor or research team.
Université de Sherbrooke
Other
Metabolic and Clinical Evaluation of Medium-Chain Triglyceride-Based Exogenous Ketone Supplementation as an Adjunctive Treatment for First-Episode Psychosis
Acronym: RECAP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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