Exogenous Ketone Ester in Women with Polycystic Ovary Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Plasma concentration of testosterone
研究概览
简要总结
Polycystic ovarian syndrome (PCOS) is characterized by elevated androgens such as testosterone. Clinical studies suggest that ketogenic diets lower the levels of androgens. The ketone 3-hydroxybutyrate (3-OHB) may play an important role in these effects and the main purpose of this study is to investigate whether a 3-OHB supplement acutely improves the hormonal and metabolic status in women with PCOS.
详细描述
Polycystic ovary syndrome (PCOS) affects 5-18% of women and is characterized by the presence of two of three of the Rotterdam criteria: Hyperandrogenism (clinical or biochemical), irregular menstrual cycles, and polycystic ovary morphology, after exclusion of other conditions that mimic PCOS. PCOS is associated with elevated levels of luteinizing hormone (LH) and unaltered levels of the follicle stimulating hormone (FSH), which leads to the characteristic hyperandrogenism (high levels of testosterone), oligo- or anovulation, and a large number of premature follicles in the ovarian. Insulin resistance causes hyperinsulinemia that decreases sex hormone binding globulin (SHBG) levels and stimulates androgen production (e.g., elevated concentrations of testosterone). Ketogenic diets are characterized by a diet low in carbohydrates, and has shown beneficial effects on weight and hormonal status in women with PCOS. Whether these improvements are mediated by ketones (e.g., 3-hydroxybutyrate, 3-OHB) or other effects related to this diet is unknown. The main purpose of this study is to investigate whether a 3-OHB supplement acutely improves the hormonal and metabolic status in women with PCOS.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PCOS diagnosis
- •age >18 years
排除标准
- •Medications affecting sex hormones (e.g. contraceptives, dopamine agonists, etc) or glucose metabolism (e.g. saxenda).
- •Anemia (Hgb < 6.0 mM)
- •Practicing ketogenic diets (e.g., low-carb diet, fasting regimes)
- •Inability to understand Danish or English
- •Ongoing cancer or other acute/chronic serious diseases (PI will determine)
结局指标
主要结局
Plasma concentration of testosterone
时间窗: 10 hours after first intervention
Paired t-test
次要结局
- plasma free testosterone(10 hours after first intervention)
- plasma glucose(10 hours after first intervention)
- Plasma LH(10 hours after first intervention)
- plasma SHBG(10 hours after first intervention)
- plasma C-peptide(10 hours after first intervention)
- plasma triglycerides(10 hours after first intervention)
- plasma cytokines (such as Tumor Necrotic Factor alpha, Interleukin 6, Lipopolysaccharide -binding protein, soluble CD163)(10 hours after first intervention)
- plasma prolactin(10 hours after first intervention)
- plasma 3-OHB(10 hours after first intervention)
- plasma free fatty acids(10 hours after first intervention)
- Plasma FSH(10 hours after first intervention)
- serum insulin(10 hours after first intervention)
- plasma cholesterol(10 hours after first intervention)
- C reactive protein(10 hours after first intervention)
- plasma estradiol(10 hours after first intervention)
- plasma keto-testosterone(10 hours after first intervention)
- Homeostatic Model Assessment for Insulin Resistance(10 hours after first intervention)