Feasibility Effects of a Low-GI, High-fibre Diet in PCOS: a Prospective Cohort Study in Remote Yunnan
Recruiting · NCT07426146 · Observational (researchers observe without assigning treatment) · Lead sponsor: Shanghai First Maternity and Infant Hospital
View the official record on ClinicalTrials.gov →Interventions studied
low glycemic index-high fiber
What this trial is about
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
Who can take part
Age range
19 Years to 40 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
2 locations listed.
- Department of Gynaecology, Gengma People's Hospital - Gengma County, Yunnan, China
- Gengma People's Hospital - Lincang, Yunnan, China