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
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