Clinical trial · Interventional
Effect of Dietary Fiber Intervention on Patients With Polycystic Ovary Syndrome
NCT05431816CI-TRIAL-00066547unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to understand the effect of dietary fiber on patients with polycystic ovary syndrome.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary intervention | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- dietary fiber intervention
- description
- Participants take a certain amount of dietary fiber per day.
- interventionNames
- Dietary Supplement: Dietary intervention
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants take a certain amount of placebo (Maltodextrin) per day.
- interventionNames
- Dietary Supplement: Dietary intervention
Primary outcomes (5)
- measure
- Changes in gut microbiota
- timeFrame
- before and after 2,4,8,12 weeks of intervention
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.