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

Обзор

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

Вмешательства

• Другое low glycemic index-high fiber
  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)

Первичные конечные точки

• insulin resistance (HOMA-IR) [Срок оценки: 12 weeks]

Вторичные конечные точки (3)

• fasting glucose and fasting insulin [Срок оценки: 12 weeks]
• six-hormone panel [Срок оценки: 12 weeks]
• pelvic ultrasonography [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 2 центра

• Department of Gynaecology, Gengma People's Hospital — Gengma County
• Gengma People's Hospital — Lincang

Идентификаторы

NCT: NCT07426146 · ShanghaiFMIH-FMU9

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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