Polycystic ovary syndrome
Conditions
Interventions
Overweight placebo group:Take 3g of maltodextrin daily, divided into two doses in the morning and evening, for 12 weeks.
Overweight Pueraria lobata Polysaccharides group:Take 3g of Pueraria polysaccharide daily, divided into two doses in the morning and evening, for 12 weeks.
Obesity placebo and metformin groups:Daily intake of 3 g of maltodextrin (in addition to the standard 2 g/day of metformin, which is not the intervention drug in this study), taken in two doses in the
Obesity Pueraria polysaccharide and metformin group:Take 3g of Pueraria lobata Polysaccharides daily (in addition to the standard 2g/day of metformin, which is not the intervention drug in this study)
Sponsors
Guangzhou Medical University, Guangzhou Women and Children's Medical Center
Eligibility
Sex/Gender
Female
Age
14 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the study and sign an informed consent form; 2. Age between 14 and 40 years old; 3. Diagnosed with PCOS according to the criteria outlined in the "International Evidence-Based Guidelines for the Assessment and Management of PCOS (2023 Edition)"; 4. BMI between 24 and 35 kg/m², using the 2022 Chinese Expert Consensus on Obesity Prevention and Control to diagnose overweight (BMI >= 24.0) and obesity (BMI >= 28); BMI between 24 and 28 is classified as the overweight group, and BMI between 28 and 35 is classified as the obese group; 5. HOMA-IR value >1.66–2.67, fasting insulin level >10–15 µU/mL, or oral glucose tolerance test (OGTT) showing impaired glucose tolerance; 6. Able to adhere to the dietary and exercise management plan required by this project; 7. Not currently participating in or having participated in other similar research projects within the past 3 months prior to intervention.
Exclusion criteria
Exclusion criteria: 1. Food allergies; 2. Pregnant or breastfeeding women: Patients who are currently pregnant or breastfeeding; 3. Patients who have participated in other interventional clinical trials within the past 3 months; 4. Severe chronic diseases: Patients with other severe diseases that affect metabolic function, such as type 2 diabetes, thyroid disorders (hyperthyroidism or hypothyroidism), Cushing's syndrome, congenital adrenal hyperplasia, or primary hyperprolactinemia; 5. Patients currently receiving medication: Patients currently using medications that affect glucose metabolism or endocrine function (such as oral contraceptives, steroids, etc.) and cannot discontinue the medication before the study begins; 6. Patients who have not used any antibiotics in the past month; 7. Severe cardiovascular diseases: including but not limited to myocardial infarction, heart failure, or other cardiovascular diseases requiring long-term medication intervention; 8. Mental or cognitive impairments: Patients with severe mental illnesses or cognitive impairments who cannot cooperate to complete the study procedures; 9. Inability to comply with study requirements: Patients who, for other reasons, cannot adhere to the study protocol or complete follow-up visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HOMA-IR;Free androstenedione index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bodyweight;BMI;waist-to-hip ratio;body composition;Regular menstrual cycle;gut microbiota;Fecal/serum metabolites;serum total cholesterol;serum LDL;serum HDL;serum triglycerides; | — |
Countries
China
Contacts
Public ContactXiaoqin Zeng
Guangzhou Medical University, Guangzhou Women and Children's Medical Center
Outcome results
None listed