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

March 28, 2013 updated by: Crystal Haskell, Northumbria University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Tyne and Wear
      • Newcastle-upon-Tyne, Tyne and Wear, United Kingdom, NE1 8ST
        • Brain, Performance and Nutrition Research Centre, Northumbria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acute withdrawal
Chronic intervention 100 mg caffeine capsules 3 times per day for 14 days. Acute intervention of placebo capsule on day 15.
Dietary supplement: Caffeine and Placebo
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.
Experimental: Acute caffeine-independent of withdrawal
Chronic intervention of placebo capsules 3 times per day for 14 days. Acute intervention of 100 mg caffeine capsule on day 15.
Dietary supplement: Placebo and Caffeine
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.
Experimental: Chronic abstinence
Chronic intervention of placebo capsules 3 times per day for 14 days. Acute intervention of placebo capsule on day 15.
Dietary supplement: Placebo
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.
Experimental: Acute caffeine-in state of withdrawal
Chronic intervention of 100 mg caffeine capsule 3 times per day for 14 days. Acute intervention of 100 mg caffeine capsule on day 15.
Dietary supplement: Caffeine
Capsule containing 100 mg caffeine, one 3 times a day for 14 days and then one capsule on day 15.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mood
Time Frame: 2 weeks
Mood will be evaluated using Visual Analogue Scales administered using COMPASS.
2 weeks
Cerebral haemodynamic
Time Frame: 2 weeks
Cerebral blood flow will be measured in a subset of participants using Near Infrared Spectroscopy (NIRS).
2 weeks
Sleep
Time Frame: 2 weeks
Quality of sleep will be measured using the Pitsburgh Sleep Quality Index (PSQI).
2 weeks
Caffeine withdrawal
Time Frame: 2 weeks
Symptoms of caffeine withdrawal will be measured using a Subjective and Somatic State Questionnaire.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northumbria University

Investigators

  • Principal Investigator: Crystal Haskell, PhD, Northumbria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

June 16, 2011

First Submitted That Met QC Criteria

June 16, 2011

First Posted (Estimate)

June 20, 2011

Study Record Updates

Last Update Posted (Estimate)

March 29, 2013

Last Update Submitted That Met QC Criteria

March 28, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24G4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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