NCT01376882

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 29, 2013

Status Verified

March 1, 2013

Enrollment Period

2 years

First QC Date

June 16, 2011

Last Update Submit

March 28, 2013

Conditions

Cognitive FunctionMoodCerebral HaemodynamicsCaffeine Withdrawal

Keywords

CaffeineWithdrawalCognitive functionMoodCerebral haemodynamics

Outcome Measures

Primary Outcomes (1)

  • Cognitive performance

    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 Outcomes (4)

  • Mood

    2 weeks

  • Cerebral haemodynamic

    2 weeks

  • Sleep

    2 weeks

  • Caffeine withdrawal

    2 weeks

Study Arms (4)

Acute withdrawal

EXPERIMENTAL

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

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.

Dietary Supplement: Placebo and Caffeine

Chronic abstinence

EXPERIMENTAL

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

Dietary Supplement: Placebo

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.

Dietary Supplement: Caffeine

Interventions

PlaceboDIETARY_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.

Chronic abstinence
Caffeine and PlaceboDIETARY_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 withdrawal
Placebo and CaffeineDIETARY_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.

Acute caffeine-independent of withdrawal
CaffeineDIETARY_SUPPLEMENT

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

Acute caffeine-in state of withdrawal

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brain, Performance and Nutrition Research Centre, Northumbria University

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

Location

Related Links

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Crystal Haskell, PhD

    Northumbria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 16, 2011

First Posted

June 20, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 29, 2013

Record last verified: 2013-03

Locations

GB(1)