Status:
UNKNOWN
Effect of Dietary Fiber Intervention on Patients With Polycystic Ovary Syndrome
Lead Sponsor:
Peking University Third Hospital
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
20-40 years
Phase:
NA
Brief Summary
The purpose of the study is to understand the effect of dietary fiber on patients with polycystic ovary syndrome.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05431816
Start Date
June 30 2022
End Date
December 31 2024
Last Update
May 19 2023
Active Locations (1)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191