Exogenous Ketone Supplementation in Females with Polycystic Ovary Syndrome

Last updated: January 20, 2025
Sponsor: McGill University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Polycystic Ovarian Syndrome

Reproductive Health

Treatment

Water

Ketone

Clinical Study ID

NCT06155708
2024-9710
  • Ages 18-40
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • All female participants will report female sex assigned at birth

  • All participants will be aged 18 to 40

  • PCOS diagnosis

Exclusion

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 exceptionof PCOS)

  • Current pregnancy or currently breastfeeding

  • Current use of medications which may affect our outcomes of interest (e.g.,anti-hypertensives, anti-androgens, metformin)

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Water
Phase:
Study Start date:
January 20, 2025
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Cardiovascular Health and Autonomic Research Laboratory

    Montréal, Quebec H2W 1S4
    Canada

    Active - Recruiting

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