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NCT07426146Recruiting

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

Source: ClinicalTrials.gov · Last updated 23 Feb 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Observational
Enrollment
56 (estimated)
First submitted
26 Jan 2026
Start date
10 Aug 2025
Primary completion date
10 Feb 2026
Lead sponsor
Shanghai First Maternity and Infant Hospital
NCT number
NCT07426146

What you commit to

  • Study type: Observational
  • Planned participants: 56
  • From 10 Aug 2025 to the primary completion date, 10 Feb 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Who the study is looking for

  • 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.

Age in the registry: 19 years to 40 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Gynaecology, Gengma People's Hospital
Coordinator of this site? Confirm its status
Gengma CountyChinaRecruiting
Gengma People's Hospital
Coordinator of this site? Confirm its status
LincangChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.