Clinical trial Recruiting at 2 sites Observational Ages 19 to 40 Women only

Low-glycemic-index, high-fiber diet for women with PCOS in rural Yunnan

Official title: Feasibility Effects of a Low-GI, High-fibre Diet in PCOS: a Prospective Cohort Study in Remote Yunnan

Run by Shanghai First Maternity and Infant Hospital · NCT07426146 · Data updated 2026-11-12

This 6-month program will test whether a culturally adapted low-glycemic-index, high-fiber diet can improve insulin resistance, hormone levels, and menstrual regularity in women with PCOS living in remote Yunnan.

More PCOS (Polycystic Ovary Syndrome) trials

Quick facts

Study typeObservational
Ages19 Years to 40 Years
SexWomen only
Enrollment56 (estimated)
SponsorShanghai First Maternity and Infant Hospital
Academic / other
Locations2 sites (Gengma County, Yunnan and 1 other locations)
StatusRecruiting
StartedAugust 10, 2025
Main results expectedFebruary 10, 2026
Study endsApril 10, 2026
Registry record updatedFebruary 23, 2026
Trial IDNCT07426146 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Women with PCOS by Rotterdam criteria, BMI ≥24 kg/m², stable weight for at least 3 months, willing to keep usual activity levels, and living in the designated study area are ideal candidates.

Probably not a fit

Women who are pregnant or lactating, have diabetes or other endocrine disorders (e.g., thyroid disease, hyperprolactinemia, Cushing’s), or who recently used hormonal contraceptives or insulin-sensitizing/anti-obesity medications are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective cohort in which women meeting Rotterdam criteria for PCOS will follow a culturally adapted low-GI, high-fiber dietary plan for six months while remaining in their usual communities. Investigators will track metabolic markers (including measures of insulin resistance), androgen levels, and menstrual cycle patterns, alongside measures of adherence and feasibility in a resource-limited setting. The intervention is tailored to local high-carbohydrate eating habits to balance nutritional goals and practicality. Outcomes will be used to generate evidence-based dietary guidance for long-term PCOS care in similar rural areas.

Why it matters

Potential benefit: If successful, the diet could improve insulin sensitivity, lower androgen levels, and help restore more regular menstrual cycles using a feasible, low-cost nutritional approach.

How similar studies have gone: Previous clinical research has shown that low-GI and high-fiber diets can improve metabolic and reproductive outcomes in PCOS, but this specific culturally adapted approach in remote Yunnan communities is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Where it's running

  • Department of Gynaecology, Gengma People's Hospital
    Gengma County, Yunnan, China
    Recruiting
  • Gengma People's Hospital
    Lincang, Yunnan, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.