Effect of Dietary Fiber Intervention on Patients With Polycystic Ovary Syndrome
NCT ID: NCT05431816
Last Updated: 2023-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
100 participants
INTERVENTIONAL
2022-06-30
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Body Fat Distribution and Its Associated Factors in Chinese Women With Polycystic Ovary Syndrome
NCT04264832
Effect of NMN (Nicotinamide Mononucleotide) on Polycystic Ovary Syndrome
NCT05305677
Lifestyle Intervention in Pregnant Women With PCOS
NCT04216485
Effect of Meal Composition on Postprandial Testosterone Concentration in Women With Polycystic Ovary Syndrome
NCT00455338
Weight Cycling on Hyperandrogenemia and Insulin Resistance in Polycystic Ovary Syndrome
NCT06545721
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
dietary fiber intervention
Participants take a certain amount of dietary fiber per day.
Dietary intervention
dietary fiber （Inulin 4g，Resistant Starch 4g，β-glucan 2g）
Placebo
Participants take a certain amount of placebo (Maltodextrin) per day.
Dietary intervention
dietary fiber （Inulin 4g，Resistant Starch 4g，β-glucan 2g）
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dietary intervention
dietary fiber （Inulin 4g，Resistant Starch 4g，β-glucan 2g）
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
20 Years
40 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peking University Third Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking University Third Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M2021570
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.