Actively Recruiting
Ketone Supplementation to Improve Heart Health in Females with Polycystic Ovary Syndrome A Study Comparing Ketone Drink and Placebo Effects on Cardiovascular Risk Factors
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 one in five females of reproductive age and is often linked with infertility and increased risk factors for cardiovascular disease, such as insulin resistance, endothelial dysfunction, and high blood pressure. Since cardiovascular disease is a leading cause of death among females in Canada, finding ways to improve heart health in those with PCOS is important. This research aims to evaluate whether taking an oral ketone supplement can improve cardiovascular health markers in females with PCOS. Participants will attend two separate visits where they will consume either a ketone monoester supplement or a placebo beverage. The ketone supplement dose will be based on body weight and mixed with water and vanilla-flavored stevia. The placebo will consist of water combined with a bitter flavor and vanilla-flavored stevia. This crossover design allows comparison of the effects of ketone supplementation versus placebo on cardiovascular health in females with PCOS and female controls matched for age and body mass index. During the study visits, participants will undergo an oral glucose tolerance test to assess blood sugar control, flow-mediated dilation testing to measure blood vessel function, and blood pressure monitoring. Researchers will also evaluate blood pressure responses during acute exercise. These tests will be done within hours after supplement ingestion to measure immediate effects. The study will track changes in blood sugar, blood pressure, and vascular function to understand how ketone supplementation impacts cardiovascular risk factors in PCOS.
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
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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