Carotid atherosclerosis
Conditions
Interventions
YST plant jam group:YST plant jam
placebo group (simulated jam):placebo (simulated jam)
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) 40 years old = 1.5 mm and <= 5.0 mm; (3) Stable treatment with rosuvastatin (dose: 5-10 mg/d) or atorvastatin (dose: 10-20 mg/d) for 4 weeks or more; (4) Can participate in the trial and carry out normal activities based on the medical history and the physical examination performed by phisicians; (5) Can maintain original eating and living habits during the trial; (6) Informed consent signed.
Exclusion criteria
Exclusion criteria: (1) Participation in other clinical trials within 4 weeks prior to randomization; (2) Use of dietary supplements known to alter lipid metabolism including fish oil and other omega-3 fatty acid containing products, or other supplements with potential to improve lipid levels within 4 weeks prior to randomization; (3) Fasting blood glucose >=7.0 mmol/L or history of diabetes mellitus; (4) Secondary hyperlipidemia due to other causes, such as liver disease, thyroid disease, chronic hypoadrenalism, or dysgammaglobulinemia; (5) History of intracerebral hemorrhage, stroke, severe arrhythmia, severe cardiopulmonary insufficiency, combined organ hemorrhage, or taking anticoagulants / dual antiplatelet agents within 1 year prior to randomization; (6) Poor hypertension control with medication (resting diastolic blood pressure >=110 mmHg or systolic blood pressure >=180 mmHg); (7) History of bariatric surgery or currently taking weight loss medication; (8) Pregnant, lactating, or currently trying to become pregnant; (9) Severe liver dysfunction (ALT or AST >1.5 times ULN); (10) Chronic kidney disease (CKD) stage 3-5 (eGFR calculated by the abbreviated MDRD equation <60 ml/min/1.73m2); (11) History of malignancy (except treated cutaneous non-melanoma without evidence of recurrence, and resected cervical intraepithelial neoplasia); (12) Severe gastrointestinal diseases, gastric ulcer, or gastric perforation; (13) Platelets <100×109/L; (14) Brain disease, mental illness, or abnormal judgment ability; (15) Hepatitis B surface antigen (HBsAg) positive; (16) History of primary immunodeficiency virus infection or human immunodeficiency virus (HIV) positive; (17) Allergic to YST plant sauce ingredients; (18) History of alcohol and/or drug abuse; (19) Presence of serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including severe hematological, renal, metabolic, gastrointestinal, endocrine and other systemic diseases; (20) Failure to take plant jam as required or incomplete data that may affect the assessment of efficacy or safety; (21) Other situations that may affect the conduct of the trial and the determination of the results judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intima-media thickness at maximum carotid plaque (long axis); | — |
Secondary
| Measure | Time frame |
|---|---|
| Intima-media thickness at maximum carotid plaque (short axis);Total cholestAverage intima-media Thickness of the carotid trunkerol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C);Total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C); | — |
Countries
China
Contacts
Public ContactZhou Yong
Shanghai General Hospital
Outcome results
None listed