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NCT06155708 | RECRUITING | PCOS

Exogenous Ketone Supplementation in Females with Polycystic Ovary Syndrome
Sponsor:

McGill University

Information provided by (Responsible Party):

Charlotte Usselman

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.

Condition or disease

PCOS

Intervention/treatment

Ketone

Water

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Exogenous Ketone Supplementation to Improve Cardiovascular Disease Risk Factors in Females with Polycystic Ovary Syndrome
Actual Study Start Date : 2025-01-20
Estimated Primary Completion Date : 2027-06
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 40 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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)
Exogenous Ketone Supplementation in Females with Polycystic Ovary Syndrome

Location Details

NCT06155708

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How to Participate

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Locations

RECRUITING

Canada, Quebec

Cardiovascular Health and Autonomic Research Laboratory

Montréal, Quebec, Canada, H2W 1S4