Evaluation of the Effect of a Combination of a Plant Extract (BSL_EP044) and Lactobacillus BSL_PS6 on Glucidic Metabolism in Women Suffering From Polycystic Ovary Syndrome and High Insulin Levels
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Plasma insulin
研究概览
简要总结
The aim of the present study is to evaluate the effect of the combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6 on parameters of the glucidic metabolism, anthropometric parameters, hormonal levels and the menstrual cycle in women with polycystic ovary syndrome and high insulin levels.
详细描述
Polycystic ovary syndrome (PCOS) is the most prevalent endocrinopathy in women, affecting 4-15% of those who are of childbearing age. It is a complex and heterogeneous disease in which the gynecological disorder coexist with metabolic problems such as insulin resistance.
The beneficial effect of the extract plant BSL-EP044 on glycemic metabolism in women with PCOS is widely studied and demonstrated and Lactobacillus BSL_PS6 appears to exert a synergistic effect by supplementing the effect of BSL-EP044. The hypothesis of our study is that the addition of the probiotic strain Lactobacillus BSL_PS6 to extract plant BSL-EP044 treatment may improve the beneficial effect of this one on insulin resistance and other metabolic alterations related to PCOS.
The main objective of the present study is to evaluate the effect of the combination of a Plant Extract (BSL_EP044) and Lactobacillus BSL_PS6 on parameters related to glycemic metabolism in women with polycystic ovary syndrome and high insulin levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Being diagnosed with polycystic ovarian syndrome according to the Rotterdam criteria.
- •HOMA values between 2.5 and
- •Body mass index of less than 35 kg/m
- •Accept freely to participate in the study and sign the informed consent document.
排除标准
- •Women in treatment with oral antidiabetics.
- •Being pregnant or intending to get pregnant.
- •Be in fertility treatment.
- •To suffer from other diseases that affect the hormonal response or that could interfere with the glucidic metabolism.
结局指标
主要结局
Plasma insulin
时间窗: 12 weeks
Levels of plasma insulin
Plasma glucose
时间窗: 12 weeks
Levels of plasma glucose
HOMA
时间窗: 12 weeks
Insulin sensitivity
次要结局
- Free testosterone(12 weeks)
- Total testosterone(12 weeks)