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NCT Number: NCT06155708

Exogenous Ketone Supplementation in Females with Polycystic Ovary Syndrome

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.

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Key information

Conditions

PCOS Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Neoplasms Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiovascular Health and Autonomic Research Laboratory

Montreal, Quebec, H2W 1S4, Canada

Location status: Recruiting

Location contact

Charlotte Usselman, Ph.D

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ketone

Dietary Supplement
  • 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

Dietary Supplement

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

Primary outcomes

  1. Glycemic responses to a 2-hr oral glucose tolerance test

    Time frame: 0-2.5 hours in the post-prandial period

    • Glucose is calculated by the area under the curve using the trapezoid method.

  2. Flow mediated dilation (FMD)

    Time frame: 30 minutes

    • Endothelial function is assessed using the standard FMD; quantified as the percent increase in diameter from rest to peak diameter observed during reactive hyperemia (%FMD). The % change in diameter reflects the ability of the vessel to dilate in response to sheer stress induced by the flow following the release of occlusion. This reflects the function of the endothelium, or release of nitric oxide.

  3. Systolic Blood Pressure (SBP)

    Time frame: 2 hours

    • SBP, measured in mmHg

  4. Diastolic Blood Pressure (DBP)

    Time frame: 2 hours

    • DBP, measured in mmHg

Secondary outcomes

  1. Insulin area under the curve

    Time frame: 0-2.5 hours in the post-prandial period

    • Insulin area under the curve during oral glucose tolerance test

  2. C-peptide

    Time frame: 0-2.5 hours in the post-prandial period

    • C-peptide area under the curve during oral glucose tolerance test

  3. Glucagon-like peptide-1 (GLP-1)

    Time frame: 0-2.5 hours in the post-prandial period

    • GLP-1 area under the curve during oral glucose tolerance test.

  4. Glucose-dependent insulinotropic polypeptide (GIP)

    Time frame: 0-2.5 hours in the post-prandial period

    • GIP area under the curve during oral glucose tolerance test.

  5. Triglycerides

    Time frame: 0-2.5 hours in the post-prandial period

    • Triglycerides area under the curve during oral glucose tolerance test

  6. Insulinogenic index

    Time frame: 0-2.5 hours in the post-prandial period

    • (Insulin at 30 min - fasting insulin)/ (plasma glucose at 30 min- fasting plasma glucose).

  7. Arterial artery blood flow

    Time frame: 0-2.5 hours in the post-prandial period

    • Calculated as the product of mean blood flow velocity (cm/sec) and cross-sectional area (2Πr2) x 60 sec/min.

  8. Shear rate and low-flow mediated vasoconstriction to the FMD

    Time frame: 30 minutes

    • Shear rate calculated as area under the curve from cuff deflation to the time of peak dilation using the trapezoidal rule, as well as low flow-mediated vasoconstriction during forearm occlusion, which provides an index of the endothelial contribution to resting vascular tone and which predicts cardiovascular disease risk.

  9. Muscle sympathetic nerve activity (MSNA)

    Time frame: 2 hours

    • Measured using microneurography, and expressed in burst/min or bursts/100 heart beats

  10. Neurovascular transduction

    Time frame: 2 hours

    • Assessed by the MSNA signal (recorded in both raw and filtered/rectified/integrated formats for subsequent analyses) and arterial blood flow extracted on a beat-by-beat basis and processed using custom transduction software.

  11. Vascular resistance

    Time frame: 2 hours

    • Calculated as mean arterial pressure divided by Finometer-derived cardiac output

  12. Capillary blood Beta-OHB concentrations

    Time frame: 0-2.5 hours in the post-prandial period

    • Measures in mmol/L

  13. Serum testosterone

    Time frame: 5 minutes

    • Measured in pg/ml.

  14. Serum sex hormone binding globulin

    Time frame: 5 minutes

    • Measured in pg/ml.

  15. Serum estradiol

    Time frame: 5 minutes

    • Measured in pg/ml.

  16. Serum Progesterone

    Time frame: 5 minutes

    • Measured in pg/ml.

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte Usselman, Ph.D

CONTACT

[email protected]

5143962140

Sponsors and collaborators

Lead sponsor

McGill University

Other

Registry information

Official study title

Exogenous Ketone Supplementation to Improve Cardiovascular Disease Risk Factors in Females with Polycystic Ovary Syndrome

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 4, 2023
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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