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临床试验/NCT00981292
NCT00981292已完成4 期

Cerebral Blood Flow, Cerebro-electrical Activity and Behavioural Effects of Epigallocatechin Gallate (EGCG) Administration in Healthy, Young Adults

Northumbria University2 个研究点 分布在 1 个国家目标入组 32 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
32
试验地点
2
主要终点
Modulation of Levels of Total Haemoglobin

研究概览

简要总结

Epigallocatechin gallate (EGCG) is the most abundant catechin (sometimes referred to as tea flavonoids) in green tea extract. A review by Nagle et al (2006) identifies that a large amount of research indicates EGCG (amongst other catechins) is responsible for most of the potential health benefits associated with green tea. EGCG is brain permeable (Nakagawa & Miyazawa, 1997), and it is considered to have neuroprotective and neurorescue effects including modulation of cell survival and cell cycle genes (Levites et al 2002).

Although there have been several human studies looking at the bioavailability of EGCG when administered in varying doses, there have been no studies that have specifically investigated the cognitive effects of this catechin in humans. Therefore, the purpose of this study is to assess the cerebral blood flow (using Near Infrared Spectroscopy), cerebro-electrical activity (EEG) and behavioural effects of EGCG. A randomised, double-blind, placebo-controlled, balanced crossover study will assess the effects of 135 mg and 270 mg pure EGCG in 24 healthy, young adults (18-35). Prior to the first active study day participants will attend a screening/training visit where relevant exclusion criteria will be assessed including any food sensitivities. They will also complete a caffeine consumption questionnaire in order to control for potential caffeine withdrawal effects as a result of restrictions of the study.

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 (consume 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

Modulation of Levels of Total Haemoglobin

时间窗: 42 minutes

This measure assessed changes in levels of total haemoglobin during the 42 minute post- dose task period. Levels are in μmol/L and represent change from baseline levels.

次要结局

  • Number of Participants With Significant Modulation of Mood.(42 minutes)
  • Number of Participants With Significant Modulation of Cognitive Performance(42 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Crystal Haskell

Research Fellow

Northumbria University

研究点 (2)

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