NCT01317524已完成不适用
The Effects of Homogenized and Unhomogenized Milk on Postprandial Metabolism in Healthy Overweight Men
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Incremental Area Under the triacylglycerol Curve
研究概览
简要总结
The purpose of this study is to compare the effects of homogenized, unhomogenized and skimmed milk on postprandial metabolism in healthy overweight men
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •aged between 18 and 70 years
- •Quetelet index between 25 - 30 kg/m2
- •mean serum triacylglycerol (≤1.7 mmol/L (31))
排除标准
- •indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus (32)
- •lactose intolerance
- •current smoker
- •familial hypercholesterolemia
- •abuse of drugs
- •more than 21 alcoholic consumptions per week
- •no stable body weight (weight gain or loss < 3 kg in the past three months)
- •use of medication or a diet known to affect serum lipid or glucose metabolism
- •severe medical conditions that might interfere with the study, such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel diseases and rheumatoid arthritis.
- •active cardiovascular disease like congestive heart failure or recent (<6 months) event (acute myocardial infarction, cerebro vascular accident)
- •use of an investigational product within the previous 1 month
- •not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in plant stanol or sterol esters 3 weeks before the start of the study
- •not willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study
- •difficult venipuncture as evidenced during the screening visits
结局指标
主要结局
Incremental Area Under the triacylglycerol Curve
时间窗: during 8 hours after meal consumption
次要结局
- Plasma inflammatory markers(during 8 hours after meal consumption)
- Markers of endothelial activation(during 8 hours after meal consumption)
研究者
研究点 (2)
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