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

NCT07426146 | Recruiting

• 1 other identifier: ShanghaiFMIH-FMU9
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 2

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

Conditions

PCOS (Polycystic Ovary Syndrome)

Outcome Measures

Primary Outcomes (1)

• insulin resistance (HOMA-IR)

  12 weeks

Secondary Outcomes (3)

• fasting glucose and fasting insulin

  12 weeks

• six-hormone panel

  12 weeks

• pelvic ultrasonography

  12 weeks

Study Arms (2)

Dietary regulation group

Other: low glycemic index-high fiber

control

Interventions

low glycemic index-high fiber OTHER

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)

Dietary regulation group

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women aged 18-40 years who have resided locally for ≥12 months and meet the diagnostic criteria for PCOS will be eligible for inclusion.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai First Maternity and Infant Hospital: lead
• Gengma People's Hospital: collaborator

Study Sites (2)

Department of Gynaecology, Gengma People's Hospital

Gengma County, Yunnan, 677500, China

RECRUITING

Gengma People's Hospital

Lincang, Yunnan, 677500, China

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Central Study Contacts

Zhiqin Chen, Doctor

CONTACT

86+13671686734; ptchen1@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 23, 2026
• Study Start: August 10, 2025
• Primary Completion: February 10, 2026
• Study Completion: April 10, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

CN (2)