Lipid-lowering and Vascular Effects of a Nutraceutical Combination in HIV-infected Patients on Stable Antiretroviral Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 主要终点
- Change from baseline in LDL-C levels at 3 months
研究概览
简要总结
The effects of a nutraceutical combination (NC) containing low-dose monacolin K and berberine on lipid profile, proprotein convertase subtilisin/kexin type 9 (PCSK9), subclinical inflammation and arterial stiffness were investigated in human immunodeficiency virus (HIV)-infected patients receiving stable antiretroviral therapy (ART).
详细描述
This is a crossover interventional study of 26 HIV-infected patients on stable ART with low density lipoprotein cholesterol (LDL-C) >100 mg/dL, not receiving any lipid-lowering treatment. After a 3-week lipid stabilization period with a standardized diet regimen, the effect of a 3-month oral NC containing red yeast rice-derived monacolin K 3 mg, berberine 500 mg, policosanol 10 mg, astaxanthin 0.5 mg, folic acid 0.2 mg and coenzyme Q10 2 mg vs no active treatment (noNC) was tested on plasma total cholesterol (TC), LDL-C, high density lipoprotein cholesterol (HDL-C), triglyceride, lipoprotein(a), PCSK9, high-sensitivity C-reactive protein (hsCRP) levels and aortic pulse wave velocity (aPWV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Patients names and allocation to arms was masked for outcomes assessors
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
- •LDL-C >100 mg/dL
- •no history of cardiovascular disease
- •stable ART for at least 6 months
排除标准
- •current or recent (≤6 months) treatment with lipid-lowering drugs
- •chronic kidney disease [estimated glomerular filtration rate (GFR) <60 ml/min]
- •liver impairment (AST and/or ALT >3 times upper limit of normal)
- •current pregnancy
- •opportunistic infections within the past 3 months,
- •having received an organ transplant/immunosuppressive therapy
研究组 & 干预措施
Nutraceutical combination (NC)
Patients on standardized diet regimen taking a NC (red yeast rice-derived monacolin K 3 mg, berberine 500 mg, policosanol 10 mg, astaxanthin 0.5 mg, folic acid 0.2 mg and coenzyme Q10 2 mg) one pill/day for 3 months
干预措施: Nutraceutical combination (NC) (Dietary Supplement)
No nutraceutical combination (noNC)
Patients on standardized diet regimen without taking any NC
干预措施: No nutraceutical combination (noNC) (Behavioral)
结局指标
主要结局
Change from baseline in LDL-C levels at 3 months
时间窗: 3 months after treatment randomization
plasma LDL-C levels
次要结局
- Change from baseline in PCSK9 levels at 3 months(3 months after treatment randomization)
- Change from baseline in subclinical inflammation at 3 months(3 months after treatment randomization)
- Change from baseline in arterial stiffness at 3 months(3 months after treatment randomization)
研究者
Matteo Pirro
Clinical Professor, Principal Investigator
University Of Perugia