Effect of Dietary Fiber Intervention on Patients With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in ovarian volume
研究概览
简要总结
The purpose of the study is to understand the effect of dietary fiber on patients with polycystic ovary syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Individuals who are 20 to 40 years old, planning to become pregnant or infertile women.
- •Individuals who are diagnosed as PCOS according to Rotterdam PCOS diagnostic criteria: 1）oligomenorrhea or amenorrhea or irregular uterine bleeding 2) hyperandrogenism or hyperandrogenism; 3) ultrasonography showing polycystic ovary, while excluding other diseases that may cause hyperandrogenism and ovulation abnormalities. Meets at least two of the three criterias.
- •Individuals who can insist on continuous monitoring in the outpatient clinic,
- •Individuals who are not participating in other research projects currently or 3 months before the intervention.
排除标准
- •Individuals who suffering from other diseases that may cause hyperandrogenism and ovulation abnormalities.
- •Individuals who are during pregnant, lactation or menopause.
- •Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months.
- •Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc.
- •Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc.
- •Use of medications that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 2 months.
- •Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study.
- •A medical history of severe cardiovascular and cerebrovascular diseases.
- •Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption.
- •Individuals who drink more than 15g of alcohol per day or have a smoking habit.
- •Individuals who need drug treatment for any mental illness such as epilepsy and depression.
- •Cancer patients.
结局指标
主要结局
Changes in ovarian volume
时间窗: before and after 12 weeks of intervention
The size of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase.
Changes in gut microbiota
时间窗: before and after 2,4,8,12 weeks of intervention
Study the gut microbiota change of stool samples between placebo group and intervention group
Changes in metabolomics
时间窗: before and after 2,4,8,12 weeks of intervention
Study the netabolomics change of stool samples between placebo group and intervention group
Changes in endocrine hormones
时间窗: before and after 12 weeks of intervention
Study the hormones change of blood samples between placebo group and intervention group
Changes in the number of follicles
时间窗: before and after 12 weeks of intervention
The number of follicles of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase.
次要结局
未报告次要终点