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临床试验/NCT01376882
NCT01376882已完成不适用

Behavioural and Cerebral Haemodynamic Effects of Caffeine Withdrawal and Caffeine Administration Following 2-week Maintenance or Abstinence

Northumbria University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2011年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Cognitive performance

研究概览

简要总结

The purpose of this study is to determine the effects of 2 weeks caffeine abstinence as compared to 2 weeks caffeine maintenance (300mg per day)on cognition and mood. Cerebral blood flow effects will also be assessed in a subset of participants. The role of caffeine abstinence/maintenance in the acute effects of caffeine will also be explored.

详细描述

The current randomised, placebo-controlled, double-blind, parallel groups study aims to explore the behavioural effects of 2-weeks caffeine abstinence as well as establishing the role of abstinence in the effects of caffeine administration by administering caffeine or placebo to those in a state of chronic and acute abstinence. This research also aims to explore, in a subset of participants, the cerebral blood flow effects of caffeine abstinence and caffeine administration using Near Infrared Spectroscopy (NIRS). Cerebral blood flow will be measured both at rest and during performance of cognitive tasks.

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Male/Female
  • •18 - 40 years
  • •Consume ≥ 150 mg caffeine daily
  • •No herbal supplements/prescription medications (excl. contraceptive pill)
  • •Non smoker
  • •Native English speaker

排除标准

  • •Diagnosis of any significant medical condition or disorder
  • •Any known allergy or hypersensitivity to food.
  • •BMI >29.9 or <18.5
  • •Blood pressure >139/89

研究组 & 干预措施

Acute withdrawal

Experimental

Chronic intervention 100 mg caffeine capsules 3 times per day for 14 days. Acute intervention of placebo capsule on day 15.

干预措施: Caffeine and Placebo (Dietary Supplement)

Acute caffeine-independent of withdrawal

Experimental

Chronic intervention of placebo capsules 3 times per day for 14 days. Acute intervention of 100 mg caffeine capsule on day 15.

干预措施: Placebo and Caffeine (Dietary Supplement)

Chronic abstinence

Experimental

Chronic intervention of placebo capsules 3 times per day for 14 days. Acute intervention of placebo capsule on day 15.

干预措施: Placebo (Dietary Supplement)

Acute caffeine-in state of withdrawal

Experimental

Chronic intervention of 100 mg caffeine capsule 3 times per day for 14 days. Acute intervention of 100 mg caffeine capsule on day 15.

干预措施: Caffeine (Dietary Supplement)

结局指标

主要结局

Cognitive performance

时间窗: 2 weeks

Performance is assessed using COMPASS (Computerised Mental Performance Assessment System), which presents a battery of standard cognitive tasks assessing aspects of attention and memory.

次要结局

  • Mood(2 weeks)
  • Cerebral haemodynamic(2 weeks)
  • Sleep(2 weeks)
  • Caffeine withdrawal(2 weeks)

研究者

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

Crystal Haskell

Dr

Northumbria University

研究点 (1)

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