Actively Recruiting
Feasibility Effects of a Low-GI, High-fibre Diet in PCOS: a Prospective Cohort Study in Remote Yunnan
Led by Shanghai First Maternity and Infant Hospital · Updated on 2026-02-23
56
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
Sponsors
S
Shanghai First Maternity and Infant Hospital
Lead Sponsor
G
Gengma People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a culturally adapted low glycemic index-high fiber (LGI-HF) diet on women with polycystic ovary syndrome (PCOS) living in remote areas of Yunnan Province. The study aims to observe changes in insulin resistance, androgen levels, and menstrual regularity over a 6-month period. This nutritional approach is designed to suit high-carbohydrate diets common in the area and balance feasibility with adherence, providing practical guidance for long-term PCOS management in resource-limited settings. The intervention includes a 24-week adaptive LGI-HF diet tailored for women with PCOS. Participants will follow the diet while maintaining their usual physical activity levels. Assessments will be conducted at the start, mid-point (12 weeks), and end (24 weeks) of the intervention to evaluate metabolic and reproductive effects. During the study, participants will undergo evaluations including insulin resistance measurement using HOMA-IR at 12 weeks, fasting glucose and insulin tests, a six-hormone panel, and pelvic ultrasonography. The study monitors adherence to the diet and documents any changes in physical activity or medication use. Participants will be involved for at least 6 months, with safety and outcome measures carefully tracked throughout the period.
CONDITIONS
Brief Title
Feasibility Effects of a Low-GI, High-fibre Diet in PCOS: a Prospective Cohort Study in Remote Yunnan
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged between 19 and 40 years
- Diagnosed with PCOS according to the Rotterdam criteria (two of three: oligo-/anovulation, hyperandrogenism, polycystic ovarian morphology)
- Body mass index (BMI) of 24 kg/m² or higher
- Stable weight (±2 kg) for at least 3 months before enrollment
- Willing to maintain current physical activity levels during the study
- Residing in the designated study area for at least 6 months
You will not qualify if you...
- Pregnant or breastfeeding
- Diagnosed with type 1 or type 2 diabetes
- Presence of 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 in the past 3 months
- Severe liver, kidney, or cardiovascular disease
- Gastrointestinal disorders incompatible with a high-fiber diet
- History of bariatric surgery
- Current participation in other dietary intervention programs
- Cognitive impairment or language barriers preventing understanding of study procedures or consent
- Initiation of new weight-loss medications or supplements during the study period
- Failure to maintain habitual physical activity during the intervention period considered a protocol violation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 24 weeks
Participants follow a low glycemic index, high-fiber diet designed to evaluate its feasibility and effects on metabolic and reproductive health in women with PCOS.
Assessments at baseline, week 12, and week 24
Trial Site Locations
Total: 2 locations
1
Department of Gynaecology, Gengma People's Hospital
Gengma County, Yunnan, China, 677500
Actively Recruiting
2
Gengma People's Hospital
Lincang, Yunnan, China, 677500
Actively Recruiting
Research Team
Z
Zhiqin Chen, Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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