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临床试验/ACTRN12607000543482
ACTRN12607000543482撤回未知

ong-term effects of regular consumption of tea-derived flavonoids on endothelial function, blood pressure and cardiovascular disease risk: a randomized controlled trial

niveristy of Western Australia0 个研究点目标入组 100 人开始时间: 2007年10月23日最近更新:
适应症

试验速览

阶段
未知
状态
撤回
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
35 Years 至 75 Years(—)
性别
All

入选标准

  • Age at start of the study > 35 and < 75 years.
  • Body Mass Index (BMI) >19 and < 35 kg/m2.
  • 4 hour day time ambulatory systolic blood pressure >120 and < 151 mmHg, and ambulatory diastolic blood pressure < 100 mmHg at screening visit.
  • No use of supplements 4 weeks prior to and during the study.
  • Haematology within the normal reference range.
  • Total cholesterol < 6.5 mmol/L, plasma creatinine and liver enzymes within normal reference range.
  • Fasting blood glucose < 6.5 mmol/L and potassium within normal reference range.
  • Willing to replace use of aspirin and aspirin-like painkillers (e.g. Ibuprofen) by paracetamol 4 weeks prior to and during the study.
  • Agreeing to be informed about medically relevant personal test-results.
  • Having access to a general practitioner (GP).
  • Informed consent signed.

排除标准

  • Being an employee or student of the University of Western Australia.
  • A recorded history or current diabetes or a recorded history of metabolic diseases, chronic gastrointestinal disorders, cardiovascular, malignancies, renal disease or psychiatric disorders.
  • Currently on a medically prescribed diet, or slimming diet or actively trying to lose weight.
  • Subjects with pulse <50 or >100 beats per minute.
  • Reported intense sporting activities > 10 hours per week.
  • Subjects who are taking more than three different classes of antihypertensive medications or who take anti-hypertensive medication that may effect the bioavailability of the test products and not able or willing to stop taking them.
  • Use of systemic antibiotics in the period of 1 month prior to the study.
  • Reported intolerance or allergy to test products.
  • Reported lactating, pregnant or wishing to become pregnant during the study.
  • Reported weight change ± 10% during a period of 6 months prior to the study.
  • Alcohol intake > 200 g alcohol/wk for women and > 300 g alcohol/wk for men.
  • Combined tea and coffee intake < than 2 cups per day.
  • Reported participation in another biomedical study 3 months before the start or during the study.
  • The habit of smoking cigarettes during the past year.
  • Reported participation in night shift work during the study period.

研究者

发起方
niveristy of Western Australia

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