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

NCT ID: NCT01376882

Last Updated: 2013-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-03-31

Brief Summary

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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

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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.

Conditions

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Cognitive Function Mood Cerebral Haemodynamics Caffeine Withdrawal

Keywords

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Caffeine Withdrawal Cognitive function Mood Cerebral haemodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Acute withdrawal

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

Group Type EXPERIMENTAL

Caffeine and Placebo

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Placebo and Caffeine

Intervention Type 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.

Chronic abstinence

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

Group Type EXPERIMENTAL

Placebo

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Caffeine

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Caffeine

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northumbria University

OTHER

Sponsor Role lead

Responsible Party

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Crystal Haskell

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Crystal Haskell, PhD

Role: PRINCIPAL_INVESTIGATOR

Northumbria University

Locations

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Brain, Performance and Nutrition Research Centre, Northumbria University

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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http://www.cognitivetesting.co.uk

COMPASS software

Other Identifiers

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24G4

Identifier Type: -

Identifier Source: org_study_id