NCT05064644已完成不适用
Lipid Lowering Effect of Plant Stanol Ester in Oat-based, Fermented Spoonable Dairy Analogue -a 3-week Randomized, Double-blind, Placebo-controlled, Parallel-group Intervention Study
Raisio Group2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2021年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Change in LDL cholesterol concentration (%)
研究概览
简要总结
The aim is to determine the effect of investigational products on serum LDL cholesterol.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed written informed consent
- •Mildly or moderately elevated plasma cholesterol levels (plasma total cholesterol 5.5-8.0 mmol/l)
- •Plasma triglyceride levels ≤ 4.0 mmol/l
- •Age 18-65 years
排除标准
- •Intolerance to oats or other ingredients of the test products
- •Severe obesity (BMI ≥ 32 kg/m2)
- •Consumption of lipid/cholesterol lowering medication (e.g. ezetimibe, PCSK9 inhibitors, resins, fibrates) 1 month prior to the screening visit and throughout the study. Statin treatment is allowed at stable dose.
- •Consumption of plant stanol or plant sterol containing food products or supplements such as Benecol, Becel pro.active, Keiju Alentaja or other foods or supplements such as beta-glucan enriched foods, red rice, berberine or any combination of these used for cholesterol lowering purpose 1 month prior the study entry (baseline blood sample)
- •History of malignant diseases like cancer within five years prior to recruitment
- •History of unstable coronary artery disease (myocardial infarction, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months
- •Diagnosed type 1 or type 2 diabetes requiring medical treatment
- •Celiac disease
- •Medically prescribed diet/treatment for slimming or a special diet like very low calorie diet or use of prescribed an obesity drug (e.g. Orlistat, Victoza)
- •Alcohol abuse (> 4 portion/per day) or recreational drug abuse
- •Pregnancy or planned pregnancy or lactating
- •Clinically significant abnormalities in screening labs
- •Participation in another clinical trial in the preceding 3 months
结局指标
主要结局
Change in LDL cholesterol concentration (%)
时间窗: 0 vs 3 weeks
Mean relative change in serum LDL cholesterol concentration during the intervention
次要结局
- HDL cholesterol concentration(0 vs 3 weeks)
- LDL cholesterol concentration(0 vs 3 weeks)
- total cholesterol concentration(0 vs 3 weeks)
- Total triglyceride concentration(0 vs 3 weeks)
- non-HDL cholesterol concentration(0 vs 3 weeks)
- NMR blood biomarkers(0 vs 3 weeks)
研究者
研究点 (2)
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