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

NCT07426146 — Recruiting, 56 participants, Shanghai First Maternity and Infant Hospital

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Registry	NCT07426146
Status	Recruiting
Study type	Observational
Enrollment	56 (Estimated)
Sponsor	Shanghai First Maternity and Infant Hospital (Other); collaborators: Gengma People's Hospital
Conditions	PCOS (Polycystic Ovary Syndrome)
Interventions	low glycemic index-high fiber (Other)
Dates	start 2025-08-10, primary completion 2026-02-10 (estimated), completion 2026-04-10 (estimated), first posted 2026-02-23, last updated 2026-02-23
Locations	2 sites in China

-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. 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

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+Arms and interventions

Arm	Type	Interventions	Description
Dietary regulation group		Other: low glycemic index-high fiber
control

low glycemic index-high fiber (Other): 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)

+Outcome measures

Primary outcomes

insulin resistance (HOMA-IR) [12 weeks]

Secondary outcomes

fasting glucose and fasting insulin [12 weeks]
six-hormone panel [12 weeks]
pelvic ultrasonography [12 weeks]

+Eligibility

Sex: Female, ages: 19 Years to 40 Years

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

+Locations (2)

Facility	City	Country	Status
Department of Gynaecology, Gengma People's Hospital	Gengma County, Yunnan	China	Recruiting
Gengma People's Hospital	Lincang, Yunnan	China	Recruiting