Comparison Between Mediterranean Diet and High Protein Diet in Women With Pcos: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- improvement in metabolic outcomes of women with pcos
研究概览
简要总结
Polycystic ovary syndrome (PCOS) affects 5-10% of women and is the most common endocrine syndrome.PCOS is associated with infertility, risk for obesity and type 2 diabetes. The elevated insulin characteristic of PCOS is likely to play a major role in its symptoms. restricted calorie High protein diet and mediterranean diet may improve insulin sensitivity and therefore lower androgen production in women with pcos women.the purpose of this study is to determine which diet is more effective in improving metabolic and reproductive outcomes.
详细描述
Polycystic ovary syndrome (PCOS) is a heterogeneous syndrome affecting 5-10% of women of reproductive age. It is characterized by elevated circulating insulin, reduced insulin sensitivity, infertility, hyperandrogenism, and a multitude of symptoms that result in a decreased quality of life. The elevated insulin characteristic of PCOS is likely to play a major role in its pathogenesis by reducing insulin sensitivity and stimulating excess androgen production hence causing an hormonal imbalance.
Low calories diets have shown to improve pcos symptoms but the optimal diet for all pcos women is still unknown.
In this study, our purpose is to compare two lowering insulin restricted calories diets in order to find the optimal diet for improving metabolic and endocrin outcomes in pcos women we will also investigate which diet has the best long lasting compliance.
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
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Polycystic ovary syndrome
排除标准
- •Pregnancy
- •Lactation 6 month prior to study
- •Known hyperandrogenism
- •More then 5 kg weight loss 6 month prior to study
- •Imbalance pituitary hormones
- •Alcohol or drug abuse
- •Chronic disease - kidney/heart/diabetes/lung
- •Psychiatric disease
- •Drug use accept contraceptive pills
结局指标
主要结局
improvement in metabolic outcomes of women with pcos
时间窗: 18 months
次要结局
- improvement in clinical symptoms: acne, hirsutism and menstrual regularity(18 months)