Effect of Dietary Fiber Intervention on Patients With Polycystic Ovary Syndrome

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

Study Overview

• Status: Recruiting
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Dietary supplement: Dietary intervention

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jie Qiao, PhD; Phone Number: +86 010-82265080; Email: jie.qiao@263.net

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: Jie Qiao, Ph.D.; Phone Number: +86 010-82265080; Email: jie.qiao@263.net
      • Principal Investigator: Jie Qiao, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: M2021570

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patients' information is requested to be confidential.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No