Recruiting

Ketone Supplementation

Sponsor:

McGill University

Code:

NCT06155708

Conditions

PCOS

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Ketone

Water

Study Details

Brief summary:

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

PCOS

Study ID

NCT06155708

Start date

Jan 20, 2025

Status verified date

Dec, 2024

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

  • All female participants will report female sex assigned at birth
  • All participants will be aged 18 to 40
  • PCOS diagnosis

Exclusion Criteria:

  • Current smokers or a prolonged history of smoking
  • Presence or history of overt cardiometabolic disease (e.g., stage 2 hypertension, diabetes, heart disease), neurologic disease, or endocrinopathy (with the exception of PCOS)
  • Current pregnancy or currently breastfeeding
  • Current use of medications which may affect our outcomes of interest (e.g., anti-hypertensives, anti-androgens, metformin)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ketone

- Ketone monoester supplement in the form of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.45ml/kg body weight) ingested with water and vanilla-flavored stevia in a total volume of 100 ml.

placebo comparator: Placebo

100 ml water combined with 10ml bitter flavor and vanilla-flavored stevia

Interventions

Ketone

- Ketone monoester supplement in the form of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.45ml/kg body weight) ingested with water and vanilla-flavored stevia in a total volume of 100 ml.

Water

100 ml water combined with 10ml bitter flavor and vanilla-flavored stevia

Primary outcome measure

  • Glycemic responses to a 2-hr oral glucose tolerance test [ Time Frame: 0-2.5 hours in the post-prandial period ]
  • Flow mediated dilation (FMD) [ Time Frame: 30 minutes ]
  • Systolic Blood Pressure (SBP) [ Time Frame: 2 hours ]
  • Diastolic Blood Pressure (DBP) [ Time Frame: 2 hours ]

Central Contacts and Locations

Central contacts

Charlotte Usselman, Ph.D

5143962140charlotte.usselman@mcgill.ca

Locations

Cardiovascular Health and Autonomic Research Laboratory

Recruiting

Montréal, Quebec, Canada, H2W 1S4

Contacts

Charlotte Usselman, Ph.D

charlotte.usselman@mcgill.ca

More Information

Sponsor

McGill University

Last update posted

Jan 22, 2025

Last verified

Dec, 2024

Keywords

  • Polycystic ovary syndrome
  • Ketone monoester ingestion
  • Insulin resistance
  • Endothelial function
  • Blood pressure
  • Oral glucose tolerance test
  • Flow mediated dilation
  • Handgrip exercise
  • Neurovascular transduction
  • Cold pressor test

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by McGill University on 2025-01-22.