Naturalis Clinical Trial for a Novel Phytosterol Formulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Lipid Profile
研究概览
简要总结
The aim of this clinical study was to determine the efficacy on plasma cholesterol-lowering of a water dispersible formulation of plant sterol (WD-PS) preparation versus plant sterol esters (PS-ester), consumed within dairy products.
详细描述
Forty-seven hyperlipidemic subjects (25 males and 22 females, age 19-75 years at baseline) completed the double-blind, randomized, crossover study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy individuals aged 19-60 yr
- •plasma LDL-C levels > 3.0mmol/l
- •TG < 4.5mmol/l
- •body mass index (BMI) between 20 and 30 kg/m2.
排除标准
- •history of recent or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 3 months
- •history of chronic use of alcohol (>2 drinks/d)
- •myocardial infarction, coronary artery bypass, sitosterolaemia, kidney disease, liver disease or other major surgical procedures within the last six months
研究组 & 干预措施
Water dispersible Plant Sterol (WD-PS)
WD-PS dairy product (a novel formulation for dispersible free sterols in aqueous media produced)2g/d of free plant sterol
干预措施: WD-PS intervention phase (Dietary Supplement)
Esterified plant sterol (PS-Ester)
PS-Ester enriched dairy product (2g/d free plant sterol)
干预措施: PS-Ester intervention phase (Dietary Supplement)
placebo
100 g/d yogurt with no added plant sterol
干预措施: placebo (Dietary Supplement)
结局指标
主要结局
Lipid Profile
时间窗: Change from Baseline in lipid profile at 4 weeks (end of the phase)
次要结局
未报告次要终点
研究者
Dr. Peter Jones
Director of the Richardson Centre for Functional Foods and Nutraceuticals
University of Manitoba