Actively Recruiting

Age: 19Years - 40Years
FEMALE
NCT07426146

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

34 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

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women diagnosed with PCOS by Rotterdam criteria (two of three: oligo-/anovulation, hyperandrogenism, polycystic ovaries) after excluding related disorders
  • Body mass index (BMI) of 24 kg/m² or higher
  • Stable weight within ±2 kg for at least 3 months before enrollment
  • Willingness to keep current physical activity levels during the study
  • Residence in the study area for at least 6 months
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Type 1 or type 2 diabetes
  • Thyroid dysfunction, hyperprolactinemia, congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors, or other metabolic endocrine disorders
  • Use of hormonal contraceptives, insulin sensitizers, or anti-obesity drugs within the past 3 months
  • Severe liver, kidney, or heart disease
  • Gastrointestinal disorders that prevent high-fiber diets
  • History of bariatric surgery
  • Participation in other dietary intervention studies
  • Cognitive or language impairments preventing understanding or consent
  • Starting new weight-loss medications or supplements during the study period

AI-Screening

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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

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Research Team

Z

Zhiqin Chen, Doctor

CONTACT

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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