Effects of Dioscorea Yam Gruel on Blood Lipid Profiles in PCI Patients With Coronary Heart Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
研究概览
简要总结
This randomized controlled trial investigated the effects of Dioscorea yam gruel on blood lipid levels in patients with coronary heart disease after percutaneous coronary intervention (PCI). A total of 72 eligible post-PCI patients were randomly assigned to the control group or the intervention group. Patients in the control group received standard post-procedural treatment and care. In addition to this standard regimen, those in the intervention group were provided with approximately 150 g of Dioscorea yam gruel daily as a partial dinner replacement for 12 consecutive weeks. Serum levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and body mass index (BMI) were measured at baseline, and at 8 weeks and 12 weeks of the intervention.
详细描述
Background:
Percutaneous coronary intervention (PCI) is an important revascularization strategy for coronary heart disease, but it cannot reverse the fundamental pathological process of atherosclerosis. Dyslipidemia is a core risk factor for disease progression. This study aimed to investigate the effects of Dioscorea yam gruel, a traditional Chinese dietary therapy, on blood lipid levels in patients after PCI.
Methods (Brief Outline):
Seventy-two post-PCI patients were randomized 1:1 to control (standard care) or intervention (standard care plus 150 g/day Dioscorea yam gruel for 12 weeks). Lipid profiles were assessed at baseline, 8 weeks, and 12 weeks. Body mass index (BMI) was measured at baseline and 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and care providers were not blinded due to the nature of the dietary intervention. Outcome assessors and data analysts were blinded to group allocation throughout the trial
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting the diagnostic criteria for coronary heart disease (2020 edition)
- •Undergoing percutaneous coronary intervention (PCI)
- •Aged between 18 and 75 years
- •Having been on a stable dose of statin therapy for at least 4 weeks prior to screening
- •Being in a stable clinical condition, conscious, providing informed consent, and participating voluntarily
排除标准
- •Low-density lipoprotein cholesterol (LDL-C) level < 70 mg/dL(<1.81mmol/L) at screening
- •Complicating with other severe diseases or diseases that affect blood lipid levels, such as malignant tumors, acute cerebrovascular disease, nephrotic syndrome, severe liver disease, Cushing's syndrome, and others
- •Pregnancy or lactation
- •Concurrently participating in other dietary or exercise intervention programs
结局指标
主要结局
未指定
次要结局
- Body Mass Index (BMI)(Baseline, Week 12)
研究者
Dongmei Zhong
Nurse-in-charge
900th Hospital of PLA Joint Logistic Support Force