Metabolic Syndrome
Conditions
Interventions
Group 1:Shen Qi Shi Wei Solid Beverage
Group 2:Ganoderma lucidum and Astragalus membranaceus solid beverage
Group 3:Corn Germ Concentrated Powder Solid Beverage
Sponsors
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Age 20–60 years (inclusive), no gender restrictions; (2) Meets at least three of the following criteria according to the Western medical diagnostic criteria for chronic metabolic syndrome (as defined in the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China" [2020 Edition]): 1) Central obesity: waist circumference =90 cm for males, =85 cm for females; 2) Hyperglycemia: fasting plasma glucose =6.1 mmol/L or 2-hour postprandial glucose =7.8 mmol/L after an oral glucose tolerance test, and/or previously diagnosed and treated diabetes; 3) Hypertension: blood pressure =130/85 mmHg (1 mmHg = 0.133 kPa), and/or previously diagnosed and treated hypertension; 4) Fasting triglycerides (TG) =1.70 mmol/L; 5) Fasting high-density lipoprotein cholesterol (HDL-C) <1.04 mmol/L. (3) Willingness to comply with the physician's intervention protocol and follow-up procedures, provide informed consent, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion Criteria (1) Patients with unstable or critical conditions: severe or unstable cardiac, hepatic, or renal insufficiency; extremely poor blood pressure control (systolic blood pressure =180 mmHg and/or diastolic blood pressure =110 mmHg); extremely poor glycemic control (fasting plasma glucose =16.7 mmol/L or at risk of acute diabetic complications); fasting triglycerides =5.6 mmol/L. (2) Patients with confirmed specific diseases: type 1 diabetes mellitus, history of acute diabetic complications, history of acute pancreatitis, or malignancy. (3) Pregnant, planning to become pregnant, or lactating women. (4) Individuals allergic to any component of the investigational product. (5) Recent history of alcohol abuse or drug misuse; inability to comply with the study protocol (e.g., dietary control, scheduled follow-up visits). (6) Individuals deemed unsuitable for participation in this trial or at high risk of loss to follow-up, as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting blood glucose level;blood lipids;Blood pressure level; | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight, Body Mass Index;Waist circumference, hip circumference, waist-to-hip ratio;Pittsburgh Sleep Quality Index (PSQI);Fatigue Scale-14 Score (FS-14);Glutathione reductase;General condition: including mental status, sleep, diet, and bowel and bladder function-key clinical symptoms.;Complete Blood Count;Urinalysis;Liver and kidney function tests; | — |
Countries
China
Contacts
Public ContactZhang Xiaoke
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Outcome results
None listed