Metabolic Syndrome
Conditions
Interventions
experimental group:The test product was reconstituted with water and administered orally, one sachet per dose, three times daily, for a consecutive period of 8 weeks.
placebo-controlled:The placebo was dissolved in water and administered orally, three times daily, one packet per time, for 8 consecutive weeks.
Sponsors
Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: [1] Aged 18–65 years, both males and females eligible; [2] Meet the diagnostic criteria for metabolic syndrome according to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2024 Edition), requiring at least 3 of the following 5 criteria: • Waist circumference: = 90 cm in males, = 85 cm in females; • Fasting plasma glucose = 6.1 mmol/L, or 2-hour plasma glucose during oral glucose tolerance test (OGTT) = 7.8 mmol/L, and/or previously diagnosed with diabetes and under treatment; • Blood pressure: systolic blood pressure = 130 mmHg or diastolic blood pressure = 85 mmHg, and/or previously diagnosed with hypertension and under treatment; • Triglycerides (TG) = 1.7 mmol/L; • High-density lipoprotein cholesterol (HDL-C) < 1.04 mmol/L; [3] Uric acid: = 420 µmol/L in males, = 360 µmol/L in females; [4] Signed informed consent.
Exclusion criteria
Exclusion criteria: [1] Currently taking, or planning to take during the trial, medications that may affect the study outcomes, including: • Antidiabetic agents: metformin, insulin, SGLT-2 inhibitors, GLP-1 receptor agonists, etc.; • Lipid-lowering agents: statins, fibrates, ezetimibe, etc.; • Weight-loss agents: orlistat, GLP-1 receptor agonists, etc.; • Systemic glucocorticoids; • Thyroid hormones (only for those with unstable dosage); • Other medications deemed by the investigator to potentially interfere with the study results. [2] Pregnant or lactating women, or those planning pregnancy during the trial period; [3] Severe cardiac, hepatic, or renal insufficiency; patients with malignant tumors or mental disorders; [4] Known or suspected history of allergy to the investigational product or its excipients; [5] Participation in another clinical trial of a drug within 1 month prior to screening enrollment; [6] Poor compliance as judged by the investigator, or any other condition considered by the investigator to make the subject unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin Resistance Index (HOMA-IR);Uric Acid; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Blood Glucose;Fasting Insulin;Glycated Hemoglobin;Triglycerides(TG);High-Density Lipoprotein Cholesterol(HDL-C);Low-Density Lipoprotein Cholesterol(LDL-C);Total Cholesterol(TC);Systolic Blood Pressure (SBP);Diastolic Blood Pressure (DBP);Waist Circumference(WC);Body Weight(BW);Body Mass Index(BMI);Urea;Creatinine(Cr);High-Sensitivity C-Reactive Protein(hs-CRP); | — |
Countries
China
Contacts
Public ContactGuochong Chen
Soochow University
Outcome results
None listed