NCT01559441已完成不适用
The Effects of Beetroot Juice on Postprandial Vascular Activity After a High-fat Meal in Overweight and Slightly Obese Men
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Vascular activity
研究概览
简要总结
Increased postprandial lipemia may increase the risk for cardiovascular diseases. An important mechanistic link between lipemia following a high-fat meal and adverse cardiovascular events is lipid-mediated endothelial activation. Therefore, it is important to identify nutrients that can neutralize this acute vascular disturbance.
The investigators hypothesize that beetroot juice, a food rich in inorganic nitrate, could improve vascular activity during the postprandial phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
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 28-35 kg/m2
- •Mean serum triacylglycerol ≤1.7 mmol/L
- •No indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
- •No current smoker
- •No diabetic patients or individuals receiving antidiabetic medication
- •No familial hypercholesterolemia
- •No abuse of drugs
- •Less than 21 alcoholic consumptions per week
- •Stable body weight (weight gain or loss <3 kg in the past three months)
- •No use of medication known to affect serum lipid metabolism
- •No severe medical conditions that might interfere with the study, such as high blood pressure, epilepsy, asthma, allergies, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
- •No active cardiovascular disease like congestive heart failure or recent (<6 months) event (acute myocardial infarction, cerebro vascular accident)
- •Willingness to stop the consumption of foods rich in nitrates 3 weeks before the start of the study. Vegetables such as beets, celery, radishes, turnips and spinach are rich in nitrates
- •Willingness to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
- •No difficult venipuncture as evidenced during the screening visits
排除标准
- •Quetelet-index between <28 or >35 kg/m2
- •Mean serum triacylglycerol ≥1.7 mmol/L
- •Indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
- •Current smoker
- •Diabetic patients or individuals receiving antidiabetic medication
- •Familial hypercholesterolemia
- •Abuse of drugs
- •More than 21 alcoholic consumptions per week
- •Unstable body weight (weight gain or loss >3 kg in the past three months)
- •Use of use of medication known to affect serum lipid metabolism
- •No severe medical conditions that might interfere with the study, such as high blood pressure, epilepsy, asthma, allergies, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory 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 foods rich in nitrates 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, during the study or for 4 weeks after completion of the study
- •Not or difficult to venipuncture as evidenced during the screening visits
结局指标
主要结局
Vascular activity
时间窗: Change from baseline at 2 hours after meal consumption
Flow-mediated dilation (FMD) of the brachial artery
次要结局
- Arterial stiffness(Change from baseline at 3 hours after meal consumption)
- Microcirculatory effects(Change from baseline at 3 hours after meal consumption)
- Metabolic risk markers related to the metabolic syndrome(During 4 hours after meal consumption)
- Postprandial lipid metabolism(During 4 hours after meal consumption)
- Postprandial glucose metabolism(During 4 hours after meal consumption)
研究者
研究点 (1)
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