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Clinical Trials/NCT01376882
NCT01376882CompletedNot Applicable

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

Northumbria University1 site in 1 country110 target enrollmentStarted: March 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
110
Locations
1
Primary Endpoint
Cognitive performance

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •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

Arms & Interventions

Acute withdrawal

Experimental

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

Intervention: 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.

Intervention: 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.

Intervention: 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.

Intervention: Caffeine (Dietary Supplement)

Outcomes

Primary Outcomes

Cognitive performance

Time Frame: 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.

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Crystal Haskell

Dr

Northumbria University

Study Sites (1)

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