Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
All Genders
Healthy Volunteers
NCT06155708

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

Age: 18Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female sex assigned at birth
  • Age between 18 and 40 years
  • Diagnosis of polycystic ovary syndrome (PCOS)
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Cardiovascular Health and Autonomic Research Laboratory

Montreal, Quebec, Canada, H2W 1S4

Actively Recruiting

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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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Exogenous Ketone Supplementation in Females with Polycystic Ovary Syndrome | DecenTrialz