Polycystic ovary syndrome (PCOS)
Conditions
Interventions
Conventional intervention group (control group):Conventional intervention group
Specific dietary intervention group (intervention group):Specific dietary intervention group
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 49 Years
Inclusion criteria
Inclusion criteria: 1. Female, 18 years = 24 kg/m^2 and a waist circumference >= 85; 3. confirmed diagnosis of PCOS, based on the 2003 Rotterdam Consensus, in the presence of two of the following three criteria: (1) oligo- and/or anovulation, (2) clinical and/or biochemical signs of hyperandrogenism, or (3) polycystic ovaries on ultrasound (at least 12 follicles per ovary of 2-9 mm in diameter and/or increased ovarian volume greater than or equal to 10 cubic millimetres); 4. menstrual disorders; 5. use of reliable non-hormonal contraception throughout the study period; 6. signing an informed consent form;
Exclusion criteria
Exclusion criteria: 1. Participants with non-classical 21-hydroxylase deficiency, hyperprolactinemia, Cushing’s disease, or adrenal tumors will be excluded from the study. 2. Participants who are postmenopausal or perimenopausal, as well as those who are pregnant, planning pregnancy, or currently lactating, will be excluded. 3. Participants with a history of substance abuse, acute infectious diseases, or diabetes mellitus will not be eligible for inclusion. 4. Participants with a history of malignancy within the past 5 years or with current malignant disease will be excluded. 5. Participants with a history of gallstones or gout will be excluded from the study. 6. Participants with poorly controlled thyroid disorders, regardless of etiology, will be excluded. 7. Participants who have been diagnosed with an eating disorder within the past 12 months will be excluded. 8. Participants with known intolerance or allergy to components of the study dietary plan, such as soy, lactose, or gluten, or those diagnosed with celiac disease, will be excluded. 9. Participants who have used medications that may affect reproductive or metabolic outcomes within the past 3 months will be excluded, including oral hormonal contraceptives or hormonal implants; anti-androgens (e.g., spironolactone, flutamide, finasteride); metformin or other insulin-sensitizing agents; clomiphene citrate or estrogen modulators; gonadotropin-releasing hormone (GnRH) modulators (e.g., leuprolide); minoxidil; weight-loss medications; or other drugs that may influence appetite, such as oral corticosteroids. 10. Participants with severe hepatic impairment, defined as alanine aminotransferase (ALT) > 100 U/L or aspartate aminotransferase (AST) > 100 U/L, will be excluded. 11. Participants with severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) < 80 mL/min, will be excluded. 12. Participants with severe cardiovascular or cerebrovascular disease, including unstable angina, heart failure classified as New York Heart Association (NYHA) class III or higher, or those in the acute phase of cerebral infarction, will be excluded. 13. Participants who are currently participating in another clinical trial will be excluded. 14. Participants with any other medical condition or circumstance that, in the opinion of the investigators, makes them unsuitable for participation will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission rate of PCOS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Waist circumference;AMH;Aspartate aminotransferase;Alanine aminotransferase;Progesterone;Fasting plasma glucose;Triglycerides;Skeletal muscle mass (SMM);Blood pressure;Weight;High-density lipoprotein cholesterol;Total cholesterol;Fasting insulin;Low-density lipoprotein cholesterol;Basal metabolic rate (BMR);Body fat percentage (BF%); | — |
Countries
China
Contacts
Public ContactShan Gao
Xuanwu Hospital Capital Medical University
Outcome results
None listed