Effects of Myo-inositol, Alpha-Lactalbumin and Folic Acid Treatment in PCOS Women of Mexico and Italy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Evaluation of Myo-inositol and alpha-lactalbumin treatment on HOMA-index
研究概览
简要总结
The main aim of this study is to evaluate the effect of myo-inositol and alpha-lactalbumin treatment on HOMA-index improvement in two different groups of women, belonging to the Mexican and Italian population, both affected by Polycystic Ovary Syndrome.
详细描述
This is an open-label clinical trial aimed at evaluating and comparing the effect of myo-inositol and alpha-lactalbumin treatment on HOMA-index improvement in two different groups of PCOS patients from the Mexican and Italian population. The addition of alpha-lactalbumin helps to increase the intestinal absorption of myo-inositol and consequently improve its effect. The scientific evidence so far available shows that these two groups of PCOS women have a different genetic, nutritional, and behavioural profile. Important factors are body mass index and insulin resistance, both increased in the Mexican women, although among them PCOS prevalence is not higher compared to many other populations. Therefore, the focus of this study is to check the effects of the combined administration of myo-inositol and alpha-lactalbumin for six months (with a control at three months) e to compare these effects between the two groups of patients, monitoring several hormonal parameters connected to the menstrual cycle regularization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PCOS diagnosis based on the Rotterdam ESHRE-ASRM consensus workshop group
- •Presence of Insulin resistance diagnosed by HOMA-Index
- •Patients belonging to the Mexican population
- •Patients belonging to the Italian population
排除标准
- •Other conditions causing ovulatory disorders and/or androgens hyper production such as: hyperprolactinemia, hypothyroidism, adrenal hyperplasia and Cushing syndrome
- •Hormonal and/or pharmacological treatments in the previous 3 months that could interfere with ovulation
- •Drastic changes in diet and physical activity
- •Treatment with products containing inositols in the previous 3 months
结局指标
主要结局
Evaluation of Myo-inositol and alpha-lactalbumin treatment on HOMA-index
时间窗: three and six months
monitoring glucose and insulin levels in blood
次要结局
- Evaluation of Myo-inositol and alpha-lactalbumin treatment on ovulation(three and six months)
- Evaluation of Myo-inositol and alpha-lactalbumin treatment on hyperandrogenism(three and six months)
研究者
Unfer Vittorio
Director
AGUNCO Obstetrics and Gynecology Centre