Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
All Genders
Healthy Volunteers
ID06155708

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

Age: 18Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female sex assigned at birth
  • Aged 18 to 40 years
  • Diagnosis of polycystic ovary syndrome (PCOS)
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Loading map...

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

Similar Trials

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here