PCOS (Polycystic Ovary Syndrome)NCT07426146
Feasibility Effects of a Low-GI, High-fibre Diet in PCOS: a Prospective Cohort Study in Remote Yunnan
An observational study of PCOS (Polycystic Ovary Syndrome), run by Shanghai First Maternity and Infant Hospital at 2 sites in China.
Trial summary
This study aims to observe the effects of a 6-month, culturally-adapted low glycemic index-high fiber (LGI-HF) dietary on IR, androgen levels, and menstrual regularity among women with PCOS in remote areas of Yunnan Province. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome)
- What is being tested?
- low glycemic index-high fiber
- How many people
- 56 participants
- Where
- 2 sitesChina
- Study dates
- 10 Aug 2025to 10 Apr 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Women aged 18-40 years who have resided locally for ≥12 months and meet the diagnostic criteria for PCOS will be eligible for inclusion.
Who may be able to join
- PCOS diagnosis will follow the Rotterdam criteria (presence of two of the following three features: oligo-/anovulation, clinical/biochemical hyperandrogenism, and polycystic ovarian morphology, with exclusion of related disorders). Additional inclusion criteria comprise: body mass index (BMI) ≥24 kg/m² (Chinese obesity threshold), stable weight for at least 3 months prior to enrollment (±2 kg), willingness to maintain current physical activity levels throughout the study period, and residence within the designated study area for a minimum of 6 months.
Who cannot join
- pregnancy or lactation; type 1 diabetes or type 2 diabetes; thyroid dysfunction, hyperprolactinemia, congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors, or other endocrine disorders affecting metabolism; use of hormonal contraceptives, insulin sensitizers, or anti-obesity medications within the past 3 months (e.g., metformin, GLP-1 receptor agonists, systemic corticosteroids, hormonal contraceptives, anti-androgens). Severe hepatic/renal/cardiovascular disease; gastrointestinal disorders incompatible with high-fiber diets; history of bariatric surgery; current participation in other dietary intervention programs; and individuals with cognitive impairment or language communication barriers who cannot comprehend the study procedures or provide informed consent. Participants will be required to maintain their habitual physical activity levels during the intervention period and must not initiate new weight-loss medications/supplements; any deviations will be documented as protocol violations
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Department of Gynaecology, Gengma People's Hospital
Gengma County, Yunnan, 677500
Xueyan Wu Doctor, 86+18806973797, 18806973797@163.com
- Recruiting
Gengma People's Hospital
Lincang, Yunnan, 677500
fan hao Doctor, 86+13671686734, syhfg512006@163.com
About this study
This study aims to observe the effects of a 6-month, culturally-adapted low glycemic index-high fiber (LGI-HF) dietary on IR, androgen levels, and menstrual regularity among women with PCOS in remote areas of Yunnan Province. We hypothesize that a nutritional strategy designed for high-carbohydrate dietary habits while balancing feasibility and adherence can significantly improve patients' metabolic and reproductive parameters, thereby providing practical evidence-based guidance for long-term PCOS management in resource-limited settings
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Being tested
- low glycemic index-high fiber
- 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.
low glycemic index-high fiberOther
This was a prospective, single-center intervention study designed to evaluate the feasibility and metabolic/reproductive effects of an adaptive low glycemic index, high-fiber diet (LGI-HF) on women with polycystic ovary syndrome (PCOS) residing in remote mountainous areas of Yunnan, China. The intervention lasted 24 weeks, with assessments at baseline (week 0), mid-intervention (week 12), and end of intervention (week 24)
| Study group | Role | What they receive |
|---|---|---|
| Dietary regulation group | Not described Receives: Other: low glycemic index-high fiber | |
| control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin resistance (HOMA-IR)
Measured: 12 weeks
Secondary outcomes (3)
fasting glucose and fasting insulin
Measured: 12 weeks
six-hormone panel
Measured: 12 weeks
pelvic ultrasonography
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start10 Aug 2025
- Primary completion10 Feb 2026 (estimated)
- Study completion10 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gengma People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426146
- Sponsor's protocol ID
- ShanghaiFMIH-FMU9
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Effects of a Low-GI, High-fibre Diet in PCOS: a Prospective Cohort Study in Remote Yunnan
- ClinicalTrials.gov ID
- NCT07426146
- Acronym / sponsor ID
- ShanghaiFMIH-FMU9
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Collaborators
- Gengma People's Hospital
- Study start
- 10 Aug 2025 (actual)
- Primary completion
- 10 Feb 2026 (estimated)
- Study completion
- 10 Apr 2026 (estimated)
- First posted
- 23 Feb 2026 (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.
This study aims to observe the effects of a 6-month, culturally-adapted low glycemic index-high fiber (LGI-HF) dietary on IR, androgen levels, and menstrual regularity among women with PCOS in remote areas of Yunnan Province. We hypothesize that a nutritional strategy designed for high-carbohydrate dietary habits while balancing feasibility and adherence can significantly improve patients' metabolic and reproductive parameters, thereby providing practical evidence-based guidance for long-term PCOS management in resource-limited settings
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary regulation group | – | Other: low glycemic index-high fiber |
| control | – | – |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women aged 18-40 years who have resided locally for ≥12 months and meet the diagnostic criteria for PCOS will be eligible for inclusion.
Key inclusion criteria (1 listed)
- PCOS diagnosis will follow the Rotterdam criteria (presence of two of the following three features: oligo-/anovulation, clinical/biochemical hyperandrogenism, and polycystic ovarian morphology, with exclusion of related disorders). Additional inclusion criteria comprise: body mass index (BMI) ≥24 kg/m² (Chinese obesity threshold), stable weight for at least 3 months prior to enrollment (±2 kg), willingness to maintain current physical activity levels throughout the study period, and residence within the designated study area for a minimum of 6 months.
Key exclusion criteria (1 listed)
- pregnancy or lactation; type 1 diabetes or type 2 diabetes; thyroid dysfunction, hyperprolactinemia, congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors, or other endocrine disorders affecting metabolism; use of hormonal contraceptives, insulin sensitizers, or anti-obesity medications within the past 3 months (e.g., metformin, GLP-1 receptor agonists, systemic corticosteroids, hormonal contraceptives, anti-androgens). Severe hepatic/renal/cardiovascular disease; gastrointestinal disorders incompatible with high-fiber diets; history of bariatric surgery; current participation in other dietary intervention programs; and individuals with cognitive impairment or language communication barriers who cannot comprehend the study procedures or provide informed consent. Participants will be required to maintain their habitual physical activity levels during the intervention period and must not initiate new weight-loss medications/supplements; any deviations will be documented as protocol violations
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 |
|---|---|---|
| low glycemic index-high fiberThis was a prospective, single-center intervention study designed to evaluate the feasibility and metabolic/reproductive effects of an adaptive low glycemic index, high-fiber diet (LGI-HF) on women with polycystic ovary syndrome (PCOS) residing in remote mountainous areas of Yunnan, China. The intervention lasted 24 weeks, with assessments at baseline (week 0), mid-intervention (week 12), and end of intervention (week 24) | Other | Dietary regulation group |
Primary outcome
insulin resistance (HOMA-IR)
Time frame: 12 weeks
3 secondary outcomes
fasting glucose and fasting insulin
Time frame: 12 weeks
six-hormone panel
Time frame: 12 weeks
pelvic ultrasonography
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PCOS (Polycystic Ovary Syndrome), run by Shanghai First Maternity and Infant Hospital at 2 sites 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhiqin Chen, Doctor (86+13671686734, ptchen1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
insulin resistance (HOMA-IR) (time frame: 12 weeks). 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 23 Feb 2026.