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临床试验/NCT02295878
NCT02295878已完成不适用

Seaweed Derived Anti-inflammatory Agents and Antioxidants

University of Ulster0 个研究点目标入组 80 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
主要终点
DNA damage in lymphocytes (Comet assay)

研究概览

简要总结

Cardiovascular disease (CVD) is currently the leading cause of death worldwide. Epidemiologic studies have shown a diet rich in plant food protects against chronic degenerative diseases especially cardiovascular disease. Many of these studies have highlighted a potential role for phenolic compounds, which are abundant secondary plant metabolites, and which provide antioxidant and anti-inflammatory properties and are increasingly being shown to have an important role in influencing critical cell signalling pathways. A less well known, but nevertheless rich source of polyphenolic compounds is seaweed. In Ascophyllum nodosum, a common brown alga in the British Isles, polyphenols have been reported to comprise up to 14% of the dry weight of the plant. Some studies suggest that the potential antioxidant and anti-inflammatory benefits of seaweed-derived polyphenols may yield highly bioactive components with commercial potential for food and pharma applications. Preliminary work in our laboratory has revealed potent antioxidant activity of Ascophyllum nodosum extracts.

Therefore, the aim of this randomised, double-blind, placebo controlled, crossover design study is to investigate the biological activity of a food grade seaweed polyphenol extract in terms of reducing oxidative damage to DNA, modulation of inflammatory responses and reduction on chronic, low level inflammation in vivo. Apparently healthy volunteers (aged 30-65 years) will be randomised to receive either a capsule containing 100mg seaweed extract or a matched placebo daily for an 8 week period, with an 8 week washout period between each treatment. Fasting blood and urine samples will be taken from each volunteer at 4 time-points during the study, at baseline and completion of the 2 treatment phases.

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
Double (Participant, Investigator)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Non-smoker
  • Omnivores and vegetarians
  • Aged 30-65 years
  • BMI >25kg/m2

排除标准

  • Pregnant/lactating women
  • Diabetes mellitus, CVD
  • Autoimmune/inflammatory disorders
  • History of neoplasm
  • Recent acute illness
  • Anti-inflammatory medication
  • Habitual use of vitamin supplements

结局指标

主要结局

DNA damage in lymphocytes (Comet assay)

时间窗: 8 weeks

To assess the DNA damage in lymphocytes using the Comet assay

次要结局

  • Intracellular cytokine analysis (Tissue Factor expression using flow cytometry)(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chris gill

Senior Lecturer

University of Ulster

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