NCT02298530已完成不适用
A Study to Determine the Acute Effects of a Tea Component on Blood Pressure and Mental Stress Challenge
Unilever R&D1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2015年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Systolic blood pressure during stress
研究概览
简要总结
Assess the effects of adding theanine to a caffeinated beverage on changes in blood pressure during acute mental stress.
详细描述
Caffeine and (mental) stress can increase blood pressure. In a typical everyday and/or work environment they commonly coincide. Tea has the reputation of being a relaxing drink. L-theanine is an amino acid found almost exclusively in tea. In a previous study it was shown that caffeine increased blood pressure, while theanine antagonised these effects. In the current study the effect of theanine to a placebo on blood pressure are directly compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy males and females
- •Women taking the contraceptive pill
- •18-45 years of age
- •BMI 20-30 kg/m2
- •Normal or corrected vision
- •Low caffeine consumers (<100mg/day)
- •Non smokers and having been a non-smoker for > 6 months
- •Fluent English
- •Normotensive (>90/60 <140/90 mmHg)
排除标准
- •Significant current or medical history of cardiovascular disease
- •Low or high STAI trait score in the opinion of the PI
- •Known sensitivity to caffeine or theanine
- •Colour blindness
- •Alcohol consumption above 14/21 units female/male resp. per week
- •Weight loss diet > 10% of bodyweight in the previous year
- •Anyone with a dependency on PI or staff of Department of Epidemiology and Public Health or being an employee of Unilever
- •Reported participation in another biomedical study < 3 months before screening
结局指标
主要结局
Systolic blood pressure during stress
时间窗: Between 30-45 minutes after test product intake
Systolic blood pressure during acute mental stress
次要结局
- Diastolic blood pressure during stress(Between 30-45 minutes after test product intake)
- Systolic blood pressure after stress(Between 45-60 minutes after test product intake)
- Diastolic blood pressure after stress(Between 45-60 minutes after test product intake)
- STAI before and immediately after stress(-15 and 45 relative to test product intake)
- UWIST before and immediately after stress(-10, 45 minutes relative to test product intake)
研究者
研究点 (1)
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