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临床试验/KCT0003081
KCT0003081已完成未知

A human study for evaluating effectiveness and safety of GF bacillus enzyme SOD on antioxidant capacity

Ewha Womans University0 个研究点目标入组 80 人开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
80

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional Study

入排标准

年龄范围
30(Year) 至 64(Year)(—)
性别
All

入选标准

  • 1) Subject who voluntarily agree to participate and signs informed consent form
  • 2) Age more than 30 year old and less than 65 years old (Ratio of men and women 1:1)
  • 3) Less than 36 of Recommended Foods Score
  • 4) Subject who comply more than one thing of the following categories
  • -150mg/dL =Blood triglycerides< 200 mg/dL
  • -200mg/dL =Blood total cholesterol< 240 mg/dL
  • -130mg/dL =Blood LDL-cholesterol< 160 mg/d

排除标准

  • 1) Impossible to performa treadmill activity
  • 2) Continuous intensive workout (more than 7 hours a week) within 3 months from the first visit
  • 3) Chronic smoker (= 10 cigarettes / day)
  • 4) Intake more than 420 g of pure alcohol a week (Soju 7bottles/week, 1bottle/day) or an alcoholic
  • 5) BMI<23 or BMI=30
  • 6) Controlling body weight or have changed of body weight more than 4kg within 4 weeks before the first visit
  • 7) Having difficult to consist the current workout habits or diet habits during the study
  • 8) Comply the following categories
  • - Treated with hormone treatment within 6 months before the first visit
  • - Have following diseases or taking relevant medicines: thromboembolism, inflammatory disease, liver disease, kidney disease, cerebrovascular disease, cancer, uterine disease, Cardiovascular disease( hypertension, stroke etc), thyroid disease, interstinal disease, diabetes or hyperlipidemia with drug treatment
  • - A mental patient
  • - Therapeutic uses of coumadin, aspirin, or other medications that influence hemostasis within four weeks of the Screening visit. Preventive use of low-dose aspirin (e.g. 100-mg a day) is allowed.
  • 9) Continuous consumption of health functional food(rasberry wine, Pycnogenol, Coenzyme Q10, meron extract, antioxidantsmultivitamin etc), prebiotics (dietary fiber, oligosaccharide etc) and probiotics (lactobacillus) within 1 months before the first visit
  • 10) Donated blood within 1 month before the first visit
  • 11) Known hypersensitivity to study product or any ingredient in study product
  • 12) Planning to be pregnant, Pregnant or lactating women
  • 13) Participation in other human study within 1 month before the first visit
  • 14) Subject who has difficult to handle smartphone
  • 15) Any condition that the principal investigator believes may put the subjects at under risk

研究者

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