NCT02065180已完成4 期
The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- total cholesterol level
研究概览
简要总结
This randomised controlled trial studies the effect of a commercially available nutritional supplement on cholesterol levels in people with metabolic syndrome and elevated cholesterol levels.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •metabolic syndrome according to ATPIII criteria 3 of the following:
- •waist circumference >88cm (in females) or >102cm (in males)
- •triglycerides >150mg/dl
- •HDL <40 (50)mg/dl in males (females)
- •blood pressure>130/85 or treatment for AHT
- •glucose >110mg/dl
排除标准
- •pregnancy
- •treatment with cholesterol lowering drugs
研究组 & 干预措施
commercially available nutrition supplement
Experimental
this group receives a commercially available nutritional supplement for a period of 2 months
干预措施: commercially available nutrition supplement (Dietary Supplement)
control group
Placebo Comparator
this group receives a placebo for a period of 2 months
干预措施: placebo (Dietary Supplement)
结局指标
主要结局
total cholesterol level
时间窗: 2 months
LDL level
时间窗: 2 months
triglyceride level
时间窗: 2 months
HDL level
时间窗: 2 months
次要结局
- 8-OH-deoxyguanosine (8-OHdG)(2 months)
- BMI(2 months)
- OxLDL(2 months)
- malondialdehyde (MDA)(2 months)
- side effects(2 months)
- waist circumference(2 months)
研究者
Veronique Verhoeven
Professor
Universiteit Antwerpen
研究点 (1)
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