Effect of Dietary Fiber Intervention on Patients With Polycystic Ovary Syndrome

Not Applicable

Recruiting

• Conditions: Polycystic Ovary Syndrome
• Interventions: Dietary Supplement: Dietary intervention

• Registration Number: NCT05431816
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-06-20
• Study First Posted: 2022-06-24
• Study Start: 2022-06-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-19
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Dietary intervention	Participants take a certain amount of placebo (Maltodextrin) per day.
dietary fiber intervention	Dietary intervention	Participants take a certain amount of dietary fiber per day.

Primary Outcome Measures

Name	Time	Method
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 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 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 endocrine hormones	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	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.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China