Polycystic Ovary Syndrome
Conditions
Brief summary
The purpose of the study is to understand the effect of dietary fiber on patients with polycystic ovary syndrome.
Interventions
DIETARY_SUPPLEMENTDietary intervention
dietary fiber （Inulin 4g，Resistant Starch 4g，β-glucan 2g）
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Individuals who are 20 to 40 years old, planning to become pregnant or infertile women. 2. 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. 3. Individuals who can insist on continuous monitoring in the outpatient clinic, 4. Individuals who are not participating in other research projects currently or 3 months before the intervention.
Exclusion criteria
1. Individuals who suffering from other diseases that may cause hyperandrogenism and ovulation abnormalities. 2. Individuals who are during pregnant, lactation or menopause. 3. Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months. 4. Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc. 5. Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc. 6. Use of medications that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 2 months. 7. Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study. 8. A medical history of severe cardiovascular and cerebrovascular diseases. 9. Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption. 10. Individuals who drink more than 15g of alcohol per day or have a smoking habit. 11. Individuals who need drug treatment for any mental illness such as epilepsy and depression. 12. Cancer patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in metabolomics | 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 gut microbiota | 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 endocrine hormones | before and after 12 weeks of intervention | Study the hormones change of blood samples between placebo group and intervention group |
| Changes in ovarian volume | 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 the number of follicles | 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. |
Countries
China
Contacts
Primary ContactJie Qiao, PhD
Outcome results
None listed