Effect of Dietary Fiber Intervention on Patients With Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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The purpose of the study is to understand the effect of dietary fiber on patients with polycystic ovary syndrome.

Official Title
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Effect of Dietary Fiber Intervention on Patients With Polycystic Ovary Syndrome

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Dietary Supplement: Dietary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dietary fiber intervention<br>Participants take a certain amount of dietary fiber per day. | Dietary Supplement: Dietary intervention<br>* dietary fiber （Inulin 4g，Resistant Starch 4g，β-glucan 2g）<br>|
| Placebo Comparator: Placebo<br>Participants take a certain amount of placebo (Maltodextrin) per day. | Dietary Supplement: Dietary intervention<br>* dietary fiber （Inulin 4g，Resistant Starch 4g，β-glucan 2g）<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in gut microbiota | Study the gut microbiota change of stool samples between placebo group and intervention group | before and after 2,4,8,12 weeks of intervention | 
| Changes in metabolomics | Study the netabolomics change of stool samples between placebo group and intervention group | before and after 2,4,8,12 weeks of intervention | 
| Changes in endocrine hormones | Study the hormones change of blood samples between placebo group and intervention group | before and after 12 weeks of intervention | 
| Changes in ovarian volume | The size of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase. | before and after 12 weeks of intervention | 
| Changes in the number of follicles | The number of follicles of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase. | before and after 12 weeks of intervention |