Polycystic Ovary SyndromeNCT05431816
Effect of Dietary Fiber Intervention on Patients With Polycystic Ovary Syndrome
A study testing Dietary intervention in people with Polycystic Ovary Syndrome, run by Peking University Third Hospital at 1 site in China.
Trial summary
The purpose of the study is to understand the effect of dietary fiber on patients with polycystic ovary syndrome. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Jie Qiao, Ph.D., +86 010-82265080, jie.qiao@263.net
Jie Qiao, Ph.D.
About this study
The purpose of the study is to understand the effect of dietary fiber on patients with polycystic ovary syndrome.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Dietary intervention
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionDietary supplement
dietary fiber （Inulin 4g，Resistant Starch 4g，β-glucan 2g）
| Study group | Role | What they receive |
|---|---|---|
| dietary fiber intervention | Experimental | Participants take a certain amount of dietary fiber per day. Receives: Dietary Supplement: Dietary intervention |
| Placebo | Placebo comparator | Participants take a certain amount of placebo (Maltodextrin) per day. Receives: Dietary Supplement: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gut microbiota
Study the gut microbiota change of stool samples between placebo group and intervention group
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: before and after 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start30 Jun 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431816
- Sponsor's protocol ID
- M2021570
- Status last verified
- Apr 2023
- First submitted
- 15 Mar 2022
- Last updated
- 19 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients' information is requested to be confidential.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Fiber Intervention on Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT05431816
- Acronym / sponsor ID
- M2021570
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to understand the effect of dietary fiber on patients with polycystic ovary syndrome.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dietary fiber intervention | Experimental | Dietary Supplement: Dietary interventionParticipants take a certain amount of dietary fiber per day. |
| Placebo | Placebo comparator | Dietary Supplement: Dietary interventionParticipants take a certain amount of placebo (Maltodextrin) per day. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary interventiondietary fiber （Inulin 4g，Resistant Starch 4g，β-glucan 2g） | Dietary supplement | Placebo, dietary fiber intervention |
Primary outcome
Changes in gut microbiota
Time frame: 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
Time frame: 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
Time frame: before and after 12 weeks of intervention
Study the hormones change of blood samples between placebo group and intervention group
Changes in ovarian volume
Time frame: 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 the number of follicles
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Individual participant dataSharing planned: No. Patients' information is requested to be confidential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Polycystic Ovary Syndrome, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Qiao, PhD (+86 010-82265080, jie.qiao@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gut microbiota (time frame: before and after 2,4,8,12 weeks of intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.