Effect of Dietary Fiber Intervention on Patients With Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

Effect of Dietary Fiber Intervention on Patients With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05431816
• Other study ID #: M2021570
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Peking University Third Hospital
• Contact: Jie Qiao, PhD
• Phone: +86 010-82265080
• Email: jie.qiao[@]263.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Dietary intervention
dietary fiber (Inulin 4g,Resistant Starch 4g,ß-glucan 2g)

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Changes in endocrine hormones	Study the hormones change of blood samples between placebo group and intervention group	before and after 12 weeks of intervention
Primary	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
Primary	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