NCT07426146 Feasibility Effects of a Low-GI, High-fibre Diet in PCOS: a Prospective Cohort Study in Remote Yunnan
| NCT ID | NCT07426146 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai First Maternity and Infant Hospital |
| Condition | PCOS (Polycystic Ovary Syndrome) |
| Study Type | OBSERVATIONAL |
| Enrollment | 56 participants |
| Start Date | 2025-08-10 |
| Primary Completion | 2026-02-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 56 participants in total. It began in 2025-08-10 with a primary completion date of 2026-02-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07426146 clinical trial?
This trial is open to female participants only, aged 19 Years or older, up to 40 Years, studying PCOS (Polycystic Ovary Syndrome). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07426146 currently recruiting?
Yes, NCT07426146 is actively recruiting participants. Contact the research team at ptchen1@hotmail.com for enrollment information.
Where is the NCT07426146 trial being conducted?
This trial is being conducted at Gengma County, China, Lincang, China.
Who is sponsoring the NCT07426146 clinical trial?
NCT07426146 is sponsored by Shanghai First Maternity and Infant Hospital. The trial plans to enroll 56 participants.