Exogenous Ketone Supplementation in Females with Polycystic Ovary Syndrome

Официальное название

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

Обзор

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.

Вмешательства

• Пищевая добавка 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.
• Пищевая добавка Water
  100 ml water combined with 10ml bitter flavor and vanilla-flavored stevia

Первичные конечные точки

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

Вторичные конечные точки (12)

• Insulin area under the curve [Срок оценки: 0-2.5 hours in the post-prandial period]
• C-peptide [Срок оценки: 0-2.5 hours in the post-prandial period]
• Glucagon-like peptide-1 (GLP-1) [Срок оценки: 0-2.5 hours in the post-prandial period]
• Glucose-dependent insulinotropic polypeptide (GIP) [Срок оценки: 0-2.5 hours in the post-prandial period]
• Triglycerides [Срок оценки: 0-2.5 hours in the post-prandial period]
• Insulinogenic index [Срок оценки: 0-2.5 hours in the post-prandial period]
• Arterial artery blood flow [Срок оценки: 0-2.5 hours in the post-prandial period]
• Shear rate and low-flow mediated vasoconstriction to the FMD [Срок оценки: 30 minutes]
• Muscle sympathetic nerve activity (MSNA) [Срок оценки: 2 hours]
• Neurovascular transduction [Срок оценки: 2 hours]
• Vascular resistance [Срок оценки: 2 hours]
• Capillary blood Beta-OHB concentrations [Срок оценки: 0-2.5 hours in the post-prandial period]

Критерии участия

Критерии включения

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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Cardiovascular Health and Autonomic Research Laboratory — Montreal

Идентификаторы

NCT: NCT06155708 · 2024-9710

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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