ACTRN12613000841774已完成2 期
A 12-week randomised, double-blind, placebo-controlled crossover trial to assess the antihypertensive potential of a novel dietary supplement (a combination of olive leaf extract, green coffee bean extract and beet powder) in borderline or mildly hypertensive but untreated adult volunteers.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
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
- 18 Years 至 80 Years(—)
- 性别
- All
入选标准
- •Age 18 to 80 years
- •Body mass index between 20 and 35kg/m2 (determined at screening/baseline visit)
- •Systolic blood pressure (130-160mmHg) and/or diastolic blood pressure (85-100mmHg) (determined at screening/baseline visit)
- •Unlikely to change medication and/or supplementation during the study
排除标准
- •A smoker or currently on nicotine therapy
- •Currently in antihypertensive medication
- •Currently on insulin therapy
- •Pregnant or currently breastfeeding
- •Unwilling to fast overnight before clinic visits
- •Unwilling to wear the ambulatory blood pressure monitor and have their blood pressure monitored for 24 hours
- •Unable to commit to the same time and day of the week for all 6 visits of the study
- •Unwilling to donate 15mL of blood sample at week 0 (baseline) and at week 6 and week 12 after intervention commencement.
- •Unwilling to maintain currently dietary and physical activity habits during the study.
- •Any conditions or medication or dietary supplement that in the opinion of the principal investigator may confound the results of the study.
研究者
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