First Episode PsychosisRECAPNCT07122531
Recovery With Exogenous Ketones and Antipsychotics
A study testing Medium chain triglyceride oil in people with First Episode Psychosis, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- First Episode Psychosis
- What is being tested?
- Medium chain triglyceride oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 26 Aug 2025to 15 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Hotel-Dieu CIUSSS de l'Estrie-CHUS
Sherbrooke, Quebec, J1H 4C4
Melanie Fortier, MSc, 1-819-821-5206, melanie.fortier2@usherbrooke.ca
Kevin Zemmour, MD
About this study
Official title: Metabolic and Clinical Evaluation of Medium-Chain Triglyceride-Based Exogenous Ketone Supplementation as an Adjunctive Treatment for First-Episode Psychosis
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.
Read more
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
- Being tested
- Medium chain triglyceride oil
- Keywords
- first episode psychosis, Schizophrenia, metabolism, ketone, medium triglyceride, antipsychosis, glucose
- Medical subject headings
- Schizophrenia, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medium chain triglyceride oilOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 12 week ketogenic supplementation | Experimental | Supplementation with 15 g of medium chain triglyceride oil, emulsified in beverage of choice, twice daily (morning and evening) for 12 weeks,. Receives: Other: Medium chain triglyceride oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma total ketones concentration
Change in plasma total ketone (acetoacetate + betahydroxybutyrate) after 12 weeks of supplementation (uM)
Measured: 12 weeks
Plasmatic glucose concentration
Change in glucose concentration (mM) after 12 weeks of supplementation (uM)
Measured: 12 weeks
Plasma Insulin concentraiton
Change in insuline concentration (UI) after 12 weeks of supplementation (uM)
Measured: 12 weeks
Plasma Glycated hemoglobin
Change in Glycated hemoglobin (%) after 12 weeks of supplementation
Measured: 12 weeks
Secondary outcomes (10)
acceptability of exogenous ketone supplementation
Participant perspectives will be collected through a short semi-structured interview and analyzed using a descriptive thematic approach.
Measured: at the end of the 12 weeks treatment
compliance rate
dose of supplement taken during the 12 weeks/ number of dose expected (%)
Measured: during 12 weeks intervention
Adverse event rate
Total number of adverse event during the intervention
Measured: 12 weeks intervention
Drop-out rate
Number of participant taht have drop-out/total number of participant included in the study
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 12 weeks
Brief Assessment of Cognition (BACS)
Change in composite score (express as Z score) of the brief assessment of cogition
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start26 Aug 2025
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First Episode PsychosisStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Uncontrolled prospective pilot study.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Cunnane, Université de Sherbrooke
- Investigators
- Kevin Zemmour, MD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122531
- Sponsor's protocol ID
- 2025 -5840
- Acronym
- RECAP
- Status last verified
- May 2026
- First submitted
- 5 Aug 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Clinical Evaluation of Medium-Chain Triglyceride-Based Exogenous Ketone Supplementation as an Adjunctive Treatment for First-Episode Psychosis
- ClinicalTrials.gov ID
- NCT07122531
- Acronym / sponsor ID
- RECAP / 2025 -5840
- Conditions
- First Episode Psychosis
- Keywords
- first episode psychosis, Schizophrenia, metabolism, ketone, medium triglyceride, antipsychosis, glucose
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Uncontrolled prospective pilot study.
| Arm | Type | Receives |
|---|---|---|
| 12 week ketogenic supplementation | Experimental | Other: Medium chain triglyceride oilSupplementation with 15 g of medium chain triglyceride oil, emulsified in beverage of choice, twice daily (morning and evening) for 12 weeks,. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medium chain triglyceride oilSupplementation 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. | Other | 12 week ketogenic supplementation |
Primary outcome
Plasma total ketones concentration
Time frame: 12 weeks
Change in plasma total ketone (acetoacetate + betahydroxybutyrate) after 12 weeks of supplementation (uM)
Plasmatic glucose concentration
Time frame: 12 weeks
Change in glucose concentration (mM) after 12 weeks of supplementation (uM)
Plasma Insulin concentraiton
Time frame: 12 weeks
Change in insuline concentration (UI) after 12 weeks of supplementation (uM)
Plasma Glycated hemoglobin
Time frame: 12 weeks
Change in Glycated hemoglobin (%) after 12 weeks of supplementation
10 secondary outcomes
acceptability of exogenous ketone supplementation
Time frame: at the end of the 12 weeks treatment
compliance rate
Time frame: during 12 weeks intervention
Adverse event rate
Time frame: 12 weeks intervention
Drop-out rate
Time frame: After 12 weeks of intervention
Glucose average (mean of glucose measured by continuous glucose monitoring)
Time frame: 12 weeks
glucose variability (SD of glucose measured by continuous glucose monitoring)
Time frame: 12 weeks
Negative symptomes
Time frame: 12 weeks
Depression status measured by the score of "Calgary Depression Scale for Schizophrenia
Time frame: 12 weeks
Brief Assessment of Cognition (BACS)
Time frame: 12 weeks
Functionning level measured by the score of the Global Assessment of functionning
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kevin Zemmour, MD principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medium chain triglyceride oil in people with First Episode Psychosis, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melanie Fortier, M.Sc (1-819-821-5206, melanie.fortier2@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma total ketones concentration (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.