Effect of Dietary Fiber Intervention on Patients With Polycystic Ovary Syndrome
Primary Purpose
Polycystic Ovary Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dietary intervention
Sponsored by
About this trial
This is an interventional basic science trial for Polycystic Ovary Syndrome
Eligibility Criteria
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.
Sites / Locations
- Peking University Third HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
dietary fiber intervention
Placebo
Arm Description
Participants take a certain amount of dietary fiber per day.
Participants take a certain amount of placebo (Maltodextrin) per day.
Outcomes
Primary Outcome Measures
Changes in gut microbiota
Study the gut microbiota change of stool samples between placebo group and intervention group
Changes in metabolomics
Study the netabolomics change of stool samples between placebo group and intervention group
Changes in endocrine hormones
Study the hormones change of blood samples between placebo group and intervention group
Changes in ovarian volume
The size of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05431816
First Posted
March 15, 2022
Last Updated
May 17, 2023
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05431816
Brief Title
Effect of Dietary Fiber Intervention on Patients With Polycystic Ovary Syndrome
Official Title
Effect of Dietary Fiber Intervention on Patients With Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of the study is to understand the effect of dietary fiber on patients with polycystic ovary syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dietary fiber intervention
Arm Type
Experimental
Arm Description
Participants take a certain amount of dietary fiber per day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants take a certain amount of placebo (Maltodextrin) per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary intervention
Intervention Description
dietary fiber (Inulin 4g,Resistant Starch 4g,β-glucan 2g)
Primary Outcome Measure Information:
Title
Changes in gut microbiota
Description
Study the gut microbiota change of stool samples between placebo group and intervention group
Time Frame
before and after 2,4,8,12 weeks of intervention
Title
Changes in metabolomics
Description
Study the netabolomics change of stool samples between placebo group and intervention group
Time Frame
before and after 2,4,8,12 weeks of intervention
Title
Changes in endocrine hormones
Description
Study the hormones change of blood samples between placebo group and intervention group
Time Frame
before and after 12 weeks of intervention
Title
Changes in ovarian volume
Description
The size of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase.
Time Frame
before and after 12 weeks of intervention
Title
Changes in the number of follicles
Description
The number of follicles of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase.
Time Frame
before and after 12 weeks of intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Qiao, PhD
Phone
+86 010-82265080
Email
jie.qiao@263.net
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Qiao, Ph.D.
Phone
+86 010-82265080
Email
jie.qiao@263.net
First Name & Middle Initial & Last Name & Degree
Jie Qiao, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Patients' information is requested to be confidential.
Learn more about this trial
Effect of Dietary Fiber Intervention on Patients With Polycystic Ovary Syndrome
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