Exogenous Ketones for First Episode Psychosis

(RECAP Trial)

Overseen By Stephen Cunnane, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Must be taking: Antipsychotics

Must not be taking: MCT oil, Ketone salts

Disqualifiers: Diabetes, Pancreatitis, Liver failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how adding exogenous ketones (a type of energy for the brain) to standard antipsychotic treatment affects young adults experiencing their first episode of psychosis. The goal is to determine if these ketones can improve brain metabolism and reduce symptoms like hallucinations, cognitive issues, and mood disturbances. Participants who have had stable antipsychotic treatment and can communicate in English or French might be suitable candidates. By testing this new approach, which uses medium chain triglyceride oil to provide exogenous ketones, the trial seeks to discover if ketones offer additional benefits for managing psychosis.

As an unphased trial, this study provides a unique opportunity to explore new treatment options that could enhance current therapies for psychosis.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. Participants must be on a stable dose of a second- or third-generation antipsychotic for at least 4 weeks before joining the study.

What prior data suggests that this treatment is safe for young adults with first episode psychosis?

Research has shown that medium chain triglyceride (MCT) oil, a type of supplement, is generally safe for use. In one study, participants took MCT oil daily for 24 weeks and reported it as safe, with only minor side effects like mild stomach upset in some cases. Another study suggested that MCT oil can improve brain function, with no major safety issues reported.

These findings come from studies on other conditions, not first episode psychosis (FEP). However, the safety information remains useful. MCT oil is already used in various diets, indicating it is generally safe. While this is the first study of MCT oil in FEP, existing evidence suggests it is usually safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for first episode psychosis, which typically include antipsychotic medications like risperidone or olanzapine, this new approach uses medium chain triglyceride (MCT) oil to provide energy to the brain in a different way. Researchers are excited because MCT oil is derived from fats and can quickly convert into ketones, offering an alternative energy source for brain cells, potentially improving mental clarity and reducing symptoms. This method is also non-invasive and can be easily incorporated into a daily routine, making it an attractive option for those seeking alternatives to traditional medications.

What evidence suggests that exogenous ketones might be an effective treatment for first episode psychosis?

Early research suggests that exogenous ketones, found in medium-chain triglyceride (MCT) oil, may benefit brain health. MCT oil provides the brain with an alternative energy source to sugar, potentially enhancing its function. Other studies have shown that taking MCT improves thinking and brain function. This trial will test the effects of MCT oil supplementation in individuals experiencing their first episode of psychosis. Although not yet tested in this specific population, ketones might address brain-related issues linked to psychosis. This treatment could potentially improve symptoms like memory problems and low motivation by enhancing the brain's energy use. ^{3 4 5 6 7}

Who Is on the Research Team?

Kevin Zemmour, MD

Principal Investigator

Université de Sherbrooke

Are You a Good Fit for This Trial?

This trial is for young adults with a first episode of psychosis or schizophrenia, who can understand and consent in French or English. They must be on a stable dose of second- or third-generation antipsychotics for at least four weeks. Excluded are those with pancreatitis, liver failure, certain metabolic disorders, recent pregnancy or breastfeeding, previous ketone diet use within the year, diabetes diagnosis, porphyria.

Inclusion Criteria

I can read and communicate in either French or English.

I understand and can sign the consent form.

Referred or self-referred to the PEP Clinic of the Estrie region, either as an outpatient or inpatient

Exclusion Criteria

I have pancreatitis or liver failure.

I have a neurodevelopmental disorder or rare genetic disease with an unknown cause.

Uncontrolled acute suicidal ideation at the time of inclusion in the PEP clinic

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 15 g of medium-chain triglyceride oil twice daily for 12 weeks, in addition to their usual diet and treatment

12 weeks

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Medium chain triglyceride oil

Trial Overview The RECAP study tests if adding medium chain triglyceride (MCT) oil to standard antipsychotic treatment improves clinical and metabolic outcomes in first episode psychosis patients. Participants will take 15g of MCT oil twice daily for 12 weeks alongside their usual treatments to see if it raises ketone levels and benefits brain metabolism.

How Is the Trial Designed?

Group I: 12 week ketogenic supplementation Experimental Treatment 1 Intervention

Supplementation with 15 g of medium chain triglyceride oil, emulsified in beverage of choice, twice daily (morning and evening) for 12 weeks,.

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4456694/

Omega-3 fatty acids in first-episode schizophrenia - PMC N-3 PUFA supplementation was found to be effective in reducing the risk of transition into psychosis in individuals at ultra-high risk of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04584346

Acute Effects of Medium Chain Triglyceride (MCT) ... While three pilot studies of ketogenic diet (KD) in PD have shown either reduction in motor scores (UPDRS) or improved cognition (memory/fluency), there are ...

3. academic.oup.com academic.oup.com/ijnp/article/23/7/434/5861311

Ketogenic Therapy in Serious Mental Illness - Oxford Academic The first suggestive clinical evidence for the potential efficacy of the ketogenic diet in psychotic disorders emerged 55 years ago in a ...

4. epilepsy.com epilepsy.com/treatment/dietary-therapies/medium-chain-triglyceride-diet

Medium Chain Triglyceride (MCT) Diet This modified MCT diet has 30 percent of the calories obtained from MCT oil or emulsion and 30 percent from long chain dietary fats.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9007652/

Examining the Effect of Consuming C8 Medium-Chain ... Adding twice daily C 8 MCT oil supplementation to the habitual diet of young, healthy humans does not appear to suppress NLRP3 inflammasome activation.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07122531

Recovery With Exogenous Ketones and Antipsychotics Exogenous ketones, such as medium-chain triglycerides (MCTs), can raise circulating ketone levels without major dietary changes. MCT ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4669977/

Pilot feasibility and safety study examining the effect of ... This study evaluated the effect of the daily consumption of an oil, composed of medium chain triglycerides (MCTs) for 24 weeks on serum ketone body ...