Clinical trial NCT05431816: Effect of Dietary Fiber Intervention on Patients With Polycystic Ovary Syndrome
Official title: Effect of Dietary Fiber Intervention on Patients With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to understand the effect of dietary fiber on patients with polycystic ovary syndrome.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in gut microbiota
timeFrame: before and after 2,4,8,12 weeks of intervention
measure: Changes in metabolomics
timeFrame: before and after 2,4,8,12 weeks of intervention
measure: Changes in endocrine hormones
timeFrame: before and after 12 weeks of intervention
measure: Changes in ovarian volume
timeFrame: before and after 12 weeks of intervention
measure: Changes in the number of follicles
timeFrame: before and after 12 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: