Actively Recruiting
Exogenous Ketone Supplementation to Improve Cardiovascular Disease Risk Factors in Females with Polycystic Ovary Syndrome
Led by McGill University · Updated on 2025-01-22
60
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Polycystic ovary syndrome (PCOS) affects many females of reproductive age and is linked to important heart health risk factors like insulin resistance, blood vessel problems, and high blood pressure. Because heart disease is a leading cause of death among females, this research aims to study how to improve cardiovascular health for females with PCOS by using a ketone supplement. The study is conducted by McGill University and compares responses in females with PCOS to those in healthy females of similar age and body size. Participants will attend two sessions on different days where they will drink either a beverage containing a ketone supplement or a placebo beverage. The ketone drink contains a specific ketone monoester given based on body weight mixed with water and vanilla stevia, while the placebo is a similar-tasting water-based drink. The study measures how these drinks affect blood sugar control, blood vessel function, blood pressure, and blood flow during exercise. During the study visits, participants will undergo a glucose tolerance test, blood pressure monitoring, and a blood vessel function test called flow-mediated dilation. Blood and other measurements will be collected over several hours after drinking the supplement or placebo. Researchers will also monitor hormones and nerve activity related to cardiovascular function. The total participation includes two study days and careful monitoring of heart and metabolic health responses to the supplements.
CONDITIONS
Brief 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
- Aged 18 to 40 years
- Diagnosis of polycystic ovary syndrome (PCOS)
You will not qualify if you...
- Current smokers or history of prolonged smoking
- History or presence of cardiometabolic, neurologic, or endocrine diseases (except PCOS)
- Currently pregnant or breastfeeding
- Use of medications affecting study outcomes (e.g., anti-hypertensives, anti-androgens, metformin)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Each treatment period lasts several hours on test days, with washout periods as per study design.
Participants receive ketone supplement or placebo in a crossover design to assess cardiovascular and metabolic responses.
Multiple visits on test days for each intervention
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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