Recruiting

Ketones with AP

Sponsor:

Université de Sherbrooke

Code:

NCT07122531

Conditions

First Episode Psychosis

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

Interventions

Medium chain triglyceride oil

Study Details

Brief summary:

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.

Conditions

First Episode Psychosis

Study ID

NCT07122531

Start date

Aug 26, 2025

Status verified date

May, 2026

Completion date

Aug 15, 2027

Anticipated

Primary completion date

Apr 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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,.

Interventions

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.

Primary outcome measure

  • Plasma total ketones concentration [ Time Frame: 12 weeks ]
  • Plasmatic glucose concentration [ Time Frame: 12 weeks ]
  • Plasma Insulin concentraiton [ Time Frame: 12 weeks ]
  • Plasma Glycated hemoglobin [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Melanie Fortier, M.Sc

1-819-821-5206melanie.fortier2@usherbrooke.ca

Stephen Cunnane, PhD

1-819-780-2220stephen.cunnane@usherbrooke.ca

Locations

Hotel-Dieu CIUSSS de l'Estrie-CHUS

Recruiting

Sherbrooke, Quebec, Canada, J1H 4C4

Contacts

Melanie Fortier, MSc

1-819-821-5206melanie.fortier2@usherbrooke.ca

Principal Investigator:

Kevin Zemmour, MD

More Information

Sponsor

Université de Sherbrooke

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • first episode psychosis
  • Schizophrenia
  • metabolism
  • ketone
  • medium triglyceride
  • antipsychosis
  • glucose

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2026-05-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.