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Status unknownNCT05431816Updated May 19, 2023

Effect of Dietary Fiber Intervention on Patients With Polycystic Ovary Syndrome

An interventional study of Dietary intervention in Polycystic Ovary Syndrome, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-05-19.

Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Polycystic Ovary Syndrome
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.

This study's planned enrollment of 100 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    dietary fiber intervention

    Participants take a certain amount of dietary fiber per day.

    Dietary Supplement: Dietary intervention

  • Placebo comparator
    Placebo

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

    Dietary Supplement: Dietary intervention

Interventions

  • Dietary supplementDietary intervention

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

06

What researchers measure

Primary outcomes

  1. Changes in gut microbiota

    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

  2. Changes in metabolomics

    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

  3. Changes in endocrine hormones

    Study the hormones change of blood samples between placebo group and intervention group

    Time frame: before and after 12 weeks of intervention

  4. Changes in ovarian volume

    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

  5. 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.

    Time frame: before and after 12 weeks of intervention

07

Study locations

1 of 1 sites recruiting
  • Peking University Third Hospital
    Beijing, Beijing 100191, China
    • Jie Qiao, Ph.D. · Contact · jie.qiao@263.net · +86 010-82265080
    • Jie Qiao, Ph.D. · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Patients' information is requested to be confidential.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05431816
Lead sponsor
Peking University Third Hospital
Responsible party
Sponsor
First posted
Jun 24, 2022
Start date
Jun 30, 2022
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
May 19, 2023

Study contacts

Jie Qiao, PhD
Contact
jie.qiao@263.net
+86 010-82265080

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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