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
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Gynaecology, Gengma People's Hospital Coordinator of this site? Confirm its status | Gengma County | China | Recruiting |
| Gengma People's Hospital Coordinator of this site? Confirm its status | Lincang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.