Dyslipidemia
Conditions
Interventions
Experimental Group:Standard Care + Probiotic Solid Beverage
Control Group:Standard Care
Sponsors
The First People's Hospital of Jinzhou District, Dalian City
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years (inclusive), regardless of gender. 2. According to the "Chinese Guidelines for Lipid Management (2023)", the subject's overall risk of atherosclerotic cardiovascular disease (ASCVD) onset is assessed, and they are evaluated as a low-risk population for primary prevention of ASCVD. 3. The patient's fasting venous plasma test shows low-density lipoprotein cholesterol (LDL-C) = 4.1 mmol/L; or LDL-C = 3.4 mmol/L, and meets any one of the following conditions: total cholesterol (TC) = 6.2 mmol/L, triglycerides (TG) = 2.3 mmol/L, high-density lipoprotein cholesterol (HDL-C) < 1.0 mmol/L. 4. The subject fully understands the study's purpose, nature, procedures, and potential adverse reactions, voluntarily agrees to participate as a subject, and signs the informed consent form before any study procedures begin. 5. The subject is able to communicate effectively with the investigator and understands and complies with all requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Use of medications affecting lipid metabolism within the past 4 weeks, including but not limited to lipid-lowering agents, hypoglycemic drugs, corticosteroids, estrogen, oral contraceptives, retinoic acid, cyclosporine, antidepressants, vascular endothelial growth factor inhibitors, aromatase inhibitors; or medications that may affect probiotic activity, such as antibiotics; or regular use of probiotic products (including consumption of yogurt and probiotic beverages), laxatives, and other drugs that can alter gastrointestinal motility. 2. Family history of dyslipidemia. 3. Secondary dyslipidemia caused by certain systemic diseases, such as diabetes mellitus, nephrotic syndrome, hypothyroidism, renal failure, systemic lupus erythematosus, glycogen storage diseases, myeloma, lipodystrophy, or acute porphyria. 4. Any surgical or medical condition that may significantly affect the absorption, distribution, metabolism, or excretion of probiotics: a. History of major gastrointestinal surgery, such as gastrectomy, gastroenterostomy, or intestinal resection; b. Current active or recurrent irritable bowel syndrome (IBS) or inflammatory bowel disease (except for subjects with a past history of IBS who have been asymptomatic for at least 6 months prior to the screening visit); c. Active ulcers or gastrointestinal bleeding; d. History of pancreatic or gallbladder disease (except for patients with a history of gallbladder disease who have undergone cholecystectomy). 5. Pregnant or lactating women. 6. Patients diagnosed with malignant tumors. 7. History of drug abuse or use of any illicit drugs within the 6 months prior to administration. 8. Subjects currently participating in other clinical trials or who have participated in other clinical studies within the past 3 months. 9. Known allergy to any component of the investigational product or its excipients. 10. Other conditions deemed by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in LDL-C from Baseline at Week 8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in LDL-C from Baseline at Week 4;Change in TC from Baseline;Change in TG from Baseline;Change in HDL-C from Baseline;Change in Apolipoprotein A1 from Baseline;Change in Apolipoprotein B from Baseline;Change in Lipoprotein(a) from Baseline;Change in Fasting Blood Glucose from Baseline;Change in Bristol Stool Form Scale Classification from Baseline;Change in Gut Microbiota Composition and Abundance from Baseline;Incidence Rate of Adverse Events/Reactions; | — |
Countries
China
Contacts
Public ContactZhao yi
The First People's Hospital of Jinzhou District, Dalian City
Outcome results
None listed