Actively Recruiting
Exogenous Ketone Supplementation in Females with Polycystic Ovary Syndrome
Led by McGill University · Updated on 2025-01-22
60
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Exogenous Ketone Supplementation in Females with Polycystic Ovary Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female sex assigned at birth
- Age between 18 and 40 years
- Diagnosis of polycystic ovary syndrome (PCOS)
You will not qualify if you...
- Current smokers or those with a long history of smoking
- History or presence of cardiometabolic diseases such as stage 2 hypertension, diabetes, or heart disease
- History or presence of neurologic disease or endocrinopathy other than PCOS
- Currently pregnant or breastfeeding
- Using medications that may affect study outcomes, including anti-hypertensives, anti-androgens, or metformin
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cardiovascular Health and Autonomic Research Laboratory
Montreal, Quebec, Canada, H2W 1S4
Actively Recruiting
Research Team
C
Charlotte Usselman, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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