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Completed

NCT Number: NCT01376882

Cognitive and Cerebral Blood Flow Effects of 2-week Caffeine Abstinence or Maintenance

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.

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Key information

Conditions

Cognitive Function Caffeine Withdrawal Cerebral Haemodynamics Mood

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brain, Performance and Nutrition Research Centre, Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male/Female
  • 18 - 40 years
  • Healthy
  • 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

Treatment and study plan

Placebo

Dietary Supplement

Inert placebo containing silica powder CAB-O-SIL-M-5Pharma (Pharmaceutical grade)CABOT GmbH. 1 Size 0 capsule 3 times a day for 14 days and 1 size 0 capsule on day 15.

Caffeine and Placebo

Dietary Supplement

100 mg Caffeine capsules 3 times per day for 14 days and 1 size 0 capsule of inert placebo containing silica powder CAB-O-SIL-M-5Pharma (Pharmaceutical grade)CABOT GmbH on day 15.

Placebo and Caffeine

Dietary Supplement

Inert placebo capsules containing silica powder CAB-O-SIL-M-5Pharma (Pharmaceutical grade)CABOT GmbH, 1 Size 0 capsule 3 times a day for 14 days and a 100mg caffeine capsule on day 15.

Caffeine

Dietary Supplement

Capsule containing 100 mg caffeine, one 3 times a day for 14 days and then one capsule on day 15.

Primary outcomes

  1. 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

  1. Mood

    Time frame: 2 weeks

    Mood will be evaluated using Visual Analogue Scales administered using COMPASS.

  2. Cerebral haemodynamic

    Time frame: 2 weeks

    Cerebral blood flow will be measured in a subset of participants using Near Infrared Spectroscopy (NIRS).

  3. Sleep

    Time frame: 2 weeks

    Quality of sleep will be measured using the Pitsburgh Sleep Quality Index (PSQI).

  4. Caffeine withdrawal

    Time frame: 2 weeks

    Symptoms of caffeine withdrawal will be measured using a Subjective and Somatic State Questionnaire.

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 20, 2011
Registry last updated
Mar 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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