Effect of Dietary Fiber Intervention on Patients With Polycystic Ovary Syndrome

NCT05431816 | Unknown

• 1 other identifier: M2021570
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

dietary fiber intervention

EXPERIMENTAL

Participants take a certain amount of dietary fiber per day.

Dietary Supplement: Dietary intervention

Placebo

PLACEBO COMPARATOR

Participants take a certain amount of placebo (Maltodextrin) per day.

Dietary Supplement: Dietary intervention

Interventions

Dietary intervention DIETARY_SUPPLEMENT

dietary fiber （Inulin 4g，Resistant Starch 4g，β-glucan 2g）

Placebo; dietary fiber intervention

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Central Study Contacts

Jie Qiao, PhD

CONTACT

+86 010-82265080; jie.qiao@263.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: June 24, 2022
• Study Start: June 30, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: May 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)