Metabolic Syndrome
Conditions
Interventions
experimental group:The investigational product (compound preparation of chicory and poria) should be dissolved in water and taken orally, two sachets per day, for 8 consecutive weeks.
placebo-controlled:The placebo (compound preparation of microcrystalline cellulose) should be dissolved in water and taken orally, two sachets per day, for 8 consecutive weeks.
Sponsors
Suzhou Municipal Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: [1] Aged 18–65 years, male or female; [2] Meet the diagnostic criteria for metabolic syndrome according to the Chinese Guidelines for the Prevention and Treatment of Diabetes (2024 Edition) (=3 of the following 5 items): • Waist circumference: =90 cm in males, =85 cm in females; • Fasting plasma glucose =6.1 mmol/L and =13.9 mmol/L, or 2-h post-load glucose (OGTT) =7.8 mmol/L, and/or previously diagnosed with diabetes and under treatment; • Blood pressure: systolic blood pressure =130 mmHg and =160 mmHg, or diastolic blood pressure =85 mmHg and =100 mmHg, and/or previously diagnosed with hypertension and under treatment; • Triglycerides (TG) =1.7 mmol/L and =6 mmol/L; • High-density lipoprotein cholesterol (HDL-C) <1.04 mmol/L; [3] Uric acid: male =420 µmol/L and =720 µmol/L, female =360 µmol/L and =600 µmol/L; [4] Signed informed consent.
Exclusion criteria
Exclusion criteria: [1] Currently taking or planning to take during the trial period any medications that may affect the study results, 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 (unstable dosage); • Other medications deemed by the investigator to potentially influence the study outcomes. [2] Pregnant or lactating women, or those planning to become pregnant during the trial period; [3] Individuals with severe cardiac, hepatic, or renal insufficiency, malignant tumors, or mental disorders; [4] Known or suspected allergy to the investigational product or its excipients; [5] Poor compliance as judged by the investigator, or any other condition that the investigator considers makes the subject unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HOMA-IR;Uric acid; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting plasma glucose;Fasting insulin;Hemoglobin A1c ; Triglycerides;High-density lipoprotein cholesterol;Low-density lipoprotein cholesterol;Total cholesterol;Liver stiffness;Liver fat (Controlled Attenuation Parameter;Blood pressure;Waist circumference;Body weight;Urea;Creatinine;High-sensitivity C-reactive protein; | — |
Countries
China
Contacts
Public ContactZhang Jianwei
Suzhou Municipal Hospital
Outcome results
None listed