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临床试验/NL-OMON40127
NL-OMON40127已完成不适用

Effects of alpha-linolenic acid on 24h-ambulatory mean arterial pressure in untreated high-normal and stage I hypertensive subjects - VASALA study

niversiteit Maastricht0 个研究点目标入组 144 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
144

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • - Aged between 40-70 years
  • - Quetelet-index between 25-35 kg/m2
  • - High-normal blood pressure or stage I hypertension
  • - Mean serum total cholesterol < 8.0 mmol/L
  • - Mean serum triacylglycerol < 4.5 mmol/L
  • - Mean plasma glucose < 7.0 mmol/L

排除标准

  • - Unstable body weight (weight gain or loss >2 kg in the past 3 months)
  • - Use of antihypertensive or anticoagulant medication
  • - Indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
  • - Usage of non-steroidal anti-inflammatory drugs (aspirin, ibuprofen, naproxen) and not able or willing to stop taking them from at least 4 weeks prior to the study
  • - Use of medication or a diet known to affect serum lipid or glucose metabolism
  • - Women taking oral contraceptives or estrogen replacement therapy
  • - Women lactating, pregnant or intend to become pregnant during study
  • - Active cardiovascular disease like congestive heart failure or recent (<6 months) event (acute myocardial infarction, cerebro vascular accident)
  • - Severe medical conditions that might interfere with the study such as diabetes mellitus, epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel diseases and rheumatoid arthritis
  • - Abuse of drugs
  • - More than 21 alcohol consumptions per week for men and 14 consumptions for women
  • - Reported intense sporting activities > 10 h/w
  • - Not possible or difficult to venipuncture as evidenced during the screening visits
  • - Use of an investigational product within the previous 30 days
  • - 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

研究者

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