Low-glycemic-index, high-fiber diet for women with PCOS in rural Yunnan
Feasibility Effects of a Low-GI, High-fibre Diet in PCOS: a Prospective Cohort Study in Remote Yunnan
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 56 (estimated) |
| Ages | 19 Years to 40 Years |
| Sex | Female |
| Sponsor | Shanghai First Maternity and Infant Hospital Academic / other |
| Locations | 2 sites (Gengma County, Yunnan and 1 other locations) |
| Trial ID | NCT07426146 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Gengma County, Yunnan and 1 other locations
- Department of Gynaecology, Gengma People's Hospital — Gengma County, Yunnan, China (Recruiting)
- Gengma People's Hospital — Lincang, Yunnan, China (Recruiting)
Study contacts
- Study coordinator: Zhiqin Chen, Doctor
- Email: ptchen1@hotmail.com
- Phone: 86+13671686734
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.