Exogenous Ketone Supplementation to Improve Cardiovascular Disease Risk Factors in Females with Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Systolic Blood Pressure (SBP)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All female participants will report female sex assigned at birth
- •All participants will be aged 18 to 40
- •PCOS diagnosis
排除标准
- •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)
结局指标
主要结局
Systolic Blood Pressure (SBP)
时间窗: 2 hours
- SBP, measured in mmHg
Glycemic responses to a 2-hr oral glucose tolerance test
时间窗: 0-2.5 hours in the post-prandial period
- Glucose is calculated by the area under the curve using the trapezoid method.
Flow mediated dilation (FMD)
时间窗: 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.
Diastolic Blood Pressure (DBP)
时间窗: 2 hours
- DBP, measured in mmHg
次要结局
- Arterial artery blood flow(0-2.5 hours in the post-prandial period)
- Glucose-dependent insulinotropic polypeptide (GIP)(0-2.5 hours in the post-prandial period)
- Triglycerides(0-2.5 hours in the post-prandial period)
- Serum estradiol(5 minutes)
- Shear rate and low-flow mediated vasoconstriction to the FMD(30 minutes)
- Serum sex hormone binding globulin(5 minutes)
- Glucagon-like peptide-1 (GLP-1)(0-2.5 hours in the post-prandial period)
- Insulin area under the curve(0-2.5 hours in the post-prandial period)
- Insulinogenic index(0-2.5 hours in the post-prandial period)
- Muscle sympathetic nerve activity (MSNA)(2 hours)
- Neurovascular transduction(2 hours)
- Capillary blood Beta-OHB concentrations(0-2.5 hours in the post-prandial period)
- C-peptide(0-2.5 hours in the post-prandial period)
- Vascular resistance(2 hours)
- Serum testosterone(5 minutes)
- Serum Progesterone(5 minutes)
研究者
Charlotte Usselman
Primary Investigator
McGill University