The goal of this clinical trial is to investigate the effects of a specific dietary program on overweight or obese patients with polycystic ovary syndrome (PCOS) through a multicenter, randomized, controlled, prospective study design.
The main questions it aims to answer are:
1. Does the specific dietary program increase the clinical remission rate of PCOS in overweight or obese patients? 2. Does the specific dietary program improve metabolic and anthropometric outcomes in overweight or obese patients with PCOS compared with conventional intervention?
Researchers will compare the effects of a specific dietary program versus conventional intervention on clinical remission rates, metabolic outcomes, and anthropometric measures in overweight or obese patients with PCOS.
Participants will:
1. Receive either a specific dietary intervention or conventional intervention for 24 weeks. 2. Undergo assessments every 12 weeks throughout the study period.
Female participants aged 18-49 years.
Body mass index (BMI) ≥ 24 kg/m² and waist circumference ≥ 85 cm.
Diagnosis of polycystic ovary syndrome (PCOS) based on the 2003 Rotterdam consensus, defined by the presence of at least two of the following three criteria: (i) Oligo-ovulation and/or anovulation; (ii) Clinical and/or biochemical signs of hyperandrogenism; (iii) Polycystic ovarian morphology on ultrasonography, defined as the presence of ≥12 follicles measuring 2-9 mm in diameter in each ovary and/or increased ovarian volume ≥10 cm³.
Menstrual irregularity.
Participants with non-classical 21-hydroxylase deficiency, hyperprolactinemia, Cushing's disease, or adrenal tumors will be excluded from the study.
Participants who are postmenopausal or perimenopausal, as well as those who are pregnant, planning pregnancy, or currently lactating, will be excluded.
Participants with a history of substance abuse, acute infectious diseases, or diabetes mellitus will not be eligible for inclusion.
Participants with a history of malignancy within the past 5 years or with current malignant disease will be excluded.
Xuanwu Hospital, Beijing
Lead sponsor
Jinan Central Hospital
Collaborator
Civil Aviation General Hospital
Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborator