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临床试验/NCT00981955
NCT00981955已完成4 期

A Randomised, Double Blind, Placebo-controlled Study to Evaluate the Effects of Caffeine and L-theanine Both Alone and in Combination on Cerebral Blood Flow, Cognition and Mood.

Northumbria University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2009年8月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
24
试验地点
2
主要终点
Cerebral blood flow

研究概览

简要总结

Although the beneficial effects of caffeine on cognition and mood have been reported in a number of studies, relatively few studies have looked at the effects of caffeine in combination with other phytonutrients despite the fact that caffeine is seldom consumed in isolation. L-theanine is a naturally occurring amino-acid found in tea, and has been used historically as a relaxing agent (Haskell et al., 2008). Few have assessed the impact of l-theanine on cognition, but of those that have, the most interesting results were obtained when l-theanine was assessed in combination with caffeine (Haskell et al., 2008). It remains unclear what is underlying the reported effects.

Near Infrared Spectroscopy (NIRS) is an emerging neuroimaging technology that is capable of determining changes in cerebral blood flow (CBF) by measuring the optical properties of oxygenated and deoxygenated blood (Bunce et al., 2006). No study to date has used NIRS to assess cerebral blood flow following treatment with either caffeine, l-theanine or a combination of both. It is anticipated that the proposed study will provide some insight into the mechanism of the previously observed effects both alone and in combination.

A randomised, double-blind, placebo controlled, balanced crossover design study will assess the effects of 75mg caffeine, 50mg l-theanine and a 75mg caffeine/50mg l-theanine combination in 24 young healthy adults (18-35). Cognitive and mood assessments will take place at baseline and at 30 minutes following treatment whilst cerebral haemodynamics are measured via the technique of NIRS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18-35
  • Either caffeine consumers (consume more than 150mg caffeine per day) or non-consumers (less than 44mg caffeine per day).

排除标准

  • Smoke or consume any tobacco products
  • Not proficient in English language
  • Pregnant (or seeking to become pregnant)
  • Taking recreational, over the counter/prescription medication (including the contraceptive pill), and/or dietary/herbal supplements
  • Have food allergies or sensitivities
  • Have history of/current head trauma, learning difficulties , ADHD, migraines or any gastric problems

结局指标

主要结局

Cerebral blood flow

时间窗: 0-80 minutes post dose

Cognitive function

时间窗: 0-70 minutes post-dose

Mood

时间窗: 85 minutes post dose

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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