Actively Recruiting

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

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

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

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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Ketone Supplementation to Improve Heart Health in Females with Polycystic Ovary Syndrome A Study Comparing Ketone Drink and Placebo Effects on Cardiovascular Risk Factors | DecenTrialz