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NCT Number: NCT07122531

Recovery With Exogenous Ketones and Antipsychotics

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

[email protected]

1-819-821-5206

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Medium chain triglyceride oil

Other

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.

Primary outcomes

  1. Plasma total ketones concentration

    Time frame: 12 weeks

    Change in plasma total ketone (acetoacetate + betahydroxybutyrate) after 12 weeks of supplementation (uM)

  2. Plasmatic glucose concentration

    Time frame: 12 weeks

    Change in glucose concentration (mM) after 12 weeks of supplementation (uM)

  3. Plasma Insulin concentraiton

    Time frame: 12 weeks

    Change in insuline concentration (UI) after 12 weeks of supplementation (uM)

  4. Plasma Glycated hemoglobin

    Time frame: 12 weeks

    Change in Glycated hemoglobin (%) after 12 weeks of supplementation

Secondary outcomes

  1. acceptability of exogenous ketone 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.

  2. compliance rate

    Time frame: during 12 weeks intervention

    dose of supplement taken during the 12 weeks/ number of dose expected (%)

  3. Adverse event rate

    Time frame: 12 weeks intervention

    Total number of adverse event during the intervention

  4. Drop-out rate

    Time frame: After 12 weeks of intervention

    Number of participant taht have drop-out/total number of participant included in the study

  5. Glucose average (mean of glucose measured by continuous glucose monitoring)

    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.

  6. glucose variability (SD of glucose measured by continuous glucose monitoring)

    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.

  7. Negative symptomes

    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)

  8. Depression status measured by the score of "Calgary Depression Scale for Schizophrenia

    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

  9. Brief Assessment of Cognition (BACS)

    Time frame: 12 weeks

    Change in composite score (express as Z score) of the brief assessment of cogition

  10. Functionning level measured by the score of the Global Assessment of functionning

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Melanie Fortier, M.Sc

CONTACT

[email protected]

1-819-821-5206

Stephen Cunnane, PhD

CONTACT

[email protected]

1-819-780-2220 ext. 45670

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

Metabolic and Clinical Evaluation of Medium-Chain Triglyceride-Based Exogenous Ketone Supplementation as an Adjunctive Treatment for First-Episode Psychosis

Acronym: RECAP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 14, 2025
Registry last updated
May 22, 2026

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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