NCT06155708 Exogenous Ketone Supplementation in Females with Polycystic Ovary Syndrome
| NCT ID | NCT06155708 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McGill University |
| Condition | PCOS |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-01-20 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-01-20 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Polycystic ovary syndrome (PCOS) affects 1 in 5 females of reproductive age. Commonly characterized as a disorder of infertility, PCOS is often accompanied by 3 potent cardiovascular disease (CVD) risk factors: insulin resistance, endothelial dysfunction, and elevated blood pressure. Accordingly, PCOS is associated with the development of CVD, the second leading cause of death in females in Canada. However, effective treatments to improve cardiovascular health in PCOS are lacking. Exogenous ketone monoester (KME) ingestion has been shown to improves outcomes associated with insulin resistance, endothelial function, and blood pressure regulation in healthy individuals and individuals predisposed to CVD. Therefore, oral ketone supplements offer a practical and effective strategy for improving cardiovascular health; however, this treatment has yet to be evaluated in PCOS. Therefore, the overall goal of this project is to employ KME ingestion to improve markers of cardiovascular health in females with PCOS. On two different days, participants will consume either a beverage containing a ketone supplement or a beverage containing a placebo supplement. The objectives are to compare responses between KME and placebo ingestion, and examine all outcomes related to cardiovascular health in females with PCOS in comparison with female controls of similar age and body mass index. The effects of KME ingestion will be quantified on: 1) glycemic control during an oral glucose tolerance test; 2) endothelial function using the flow-mediated dilation test; 3) blood pressure and acute blood pressure regulation; and 4) hemodynamic responses to acute exercise.
Eligibility Criteria
Inclusion Criteria: * All female participants will report female sex assigned at birth * All participants will be aged 18 to 40 * PCOS diagnosis Exclusion Criteria: * Current smokers or a prolonged history of smoking * Presence or history of overt cardiometabolic disease (e.g., stage 2 hypertension, diabetes, heart disease), neurologic disease, or endocrinopathy (with the exception of PCOS) * Current pregnancy or currently breastfeeding * Current use of medications which may affect our outcomes of interest (e.g., anti-hypertensives, anti-androgens, metformin)
Contact & Investigator
Charlotte Usselman, Ph.D
PRINCIPAL INVESTIGATOR
McGill University
Frequently Asked Questions
Who can join the NCT06155708 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying PCOS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06155708 currently recruiting?
Yes, NCT06155708 is actively recruiting participants. Contact the research team at charlotte.usselman@mcgill.ca for enrollment information.
Where is the NCT06155708 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT06155708 clinical trial?
NCT06155708 is sponsored by McGill University. The principal investigator is Charlotte Usselman, Ph.D at McGill University. The trial plans to enroll 60 participants.