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临床试验/NCT02077660
NCT02077660已完成不适用

The Effect of Green Tea on Anthropometric, Oxidation and Inflammation Parameters in Physically Active Elderly Compared to Sedentary Elderly

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2011年11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
43
试验地点
1
主要终点
Saliva enzymatic antioxidants

研究概览

简要总结

The purpose of this study is to evaluate the beneficial effects of a long term (12 weeks) green tea drinking on plasma, erythrocytes and saliva oxidative stress biomarkers and antioxidant capacity, as well as on cardiometabolic risk factors: anthropometric, inflammation and metabolic parameters in a healthy aging men and women.

详细描述

A prospective, crossover trial in which every individual served its own control. All subjects undergo a four weeks washout period, during which they briefed to avoid tea drinking and antioxidant supplements until the end of the study. At the end of the washout period, blood and saliva samples is collected after 12 hours of night fast. Subsequently, all subjects receive the maltodextrin containing placebo "tea bags". The subjects instructed to brew the placebo sachets for five minute in 240 mL boiling water without stirring and to drink 4 cups per day for 12 weeks period (placebo period). After the placebo period, fasting samples collected once more and the subjects receive the green tea bags. Preparation and drinking instructions are the same as the placebo drink. At the end of the 12 weeks, green tea drinking, fasting blood and saliva samples drawn for the third time. During the study, every 4 weeks the subjects get additional placebo or green tea bags. Assessment of nutritional consumption of macronutrients and antioxidants using a food diary, physical activity lifestyle as well as weight, body fat and circumference measurements is made at the beginning, middle and end of the study.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
60 Years 至 76 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy men and women
  • Age: 60-76 Years
  • Able to understand the meaning of Informed Consent procedure and willing to consent

排除标准

  • Any active disease state
  • Unstable chronic disease (diabetes, vascular, renal)

结局指标

主要结局

Saliva enzymatic antioxidants

时间窗: 24 weeks

Oral peroxidase activity, milliunits/mg

Saliva antioxidant capacity

时间窗: 24 weeks

Total antioxidant capacity, millimolar/mg

Plasma protein carbonyls

时间窗: 24 weeks

Protein carbonyls, nmol/mg

Plasma thiobarbituric acid reactive substance

时间窗: 24 weeks

Thiobarbituric acid reactive substance , nmol/mL

Plasma lipid peroxides

时间窗: 24 weeks

Lipid peroxides, nmol/mL

Erythrocytes catalase

时间窗: 24 weeks

Catalase activity, milliunits/mg

Erythrocytes resistance to oxidative hemolysis

时间窗: 24 weeks

hemolysis test, percentage

次要结局

  • Total body weight(24 weeks)
  • Total body fat percentage(24 weeks)
  • Body circumference(24 weeks)
  • Serum inflammatory status(24 weeks)
  • Saliva inflammatory status Saliva matrix metalloproteinase 8 (MMP8)(24 weeks)
  • Saliva inflammatory status - saliva interleukin 8 (IL8)(24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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