Evaluating the Efficacy of AI-Guided vs. Standard Physician-Guided Dietary Supplement Prescriptions for Lowering LDL Cholesterol in Hypercholesterolemic Patients: A Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- change in LDL-C
研究概览
简要总结
The trial compared AI-guided and standard physician-guided dietary supplement (DS) prescriptions for lowering LDL cholesterol (LDL-C) in hypercholesterolemic patients. The AI system used genetic, metabolic, and clinical data to personalize DS regimens, hypothesizing superior efficacy over traditional methods. This 3-month randomized, controlled trial involved adults aged 40-75 with specific LDL-C levels, excluding those with significant health risks. Participants were divided into a control group with physician-guided DS and an AI-guided group. The AI system from Triangel Scientific provided dynamic, personalized recommendations. Baseline and follow-up measurements included lipid profiles and adherence assessments. The AI-guided group showed significantly greater LDL-C reduction and improvement in other lipid markers. The study concluded that AI-guided DS prescriptions are more effective, suggesting a promising future for AI in personalized cholesterol management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 40 and 75 years.
- •LDL-C level between 70 and 190 mg/dL, confirmed in at least two sequential checks conducted within the last six months prior to signing the consent form.
排除标准
- •Personal history of cardiovascular disease or high risk (≥ 20%).
- •Triglycerides (TG) ≥ 400 mg/dL.
- •Body Mass Index (BMI) ≥ 35 kg/m²
- •Use of lipid-lowering drugs or supplements affecting lipid metabolism within the last three months.
- •Diabetes mellitus.
- •Known severe or uncontrolled thyroid, liver, renal, or muscle diseases.
结局指标
主要结局
change in LDL-C
时间窗: 180 days
次要结局
- Percent change in high-sensitivity C-reactive protein ((180 days)
- Percent change in high-density lipoprotein cholesterol(180 days)
- Percent change in total cholesterol.(180 days)
- Percent change in serum triglycerides between the groups.(180 days)