NCT02061982

Brief Summary

Subjects will perform experiments in an at home-setting. The effect of caffeine in coffee will be tested in subjects with computer tests on attention and alertness. Comparison of the results with published results from controlled experiments will indicate the effectiveness of home experiments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2013

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 9, 2014

Status Verified

May 1, 2014

Enrollment Period

1 month

First QC Date

November 12, 2013

Last Update Submit

May 8, 2014

Conditions

At Home SettingCoffee With or Without Caffeine

Keywords

Do It Yourself (DIY)CaffeineCognition

Outcome Measures

Primary Outcomes (1)

  • Evaluate at home tests with controlled tests in experiment in metabolic ward

    Compare results of cognitive tests in an at home setting versus the results of cognitive tests in a controlled setting in a metabolic ward. Each test costs 1.5h; there will be four test days. This evaluation will partly depend upon the actual number of subjects completing the tests in this at home set-up.

    1.5 hour

Secondary Outcomes (1)

  • The effect of coffee with and without caffeine on alertness and attention

    1.5 hour on four test days

Study Arms (2)

Caffeine

EXPERIMENTAL

Instant coffee with or without caffeine will be provided

Dietary Supplement: Coffee consumption

Coffee without caffeine

PLACEBO COMPARATOR

Coffee without caffeine

Dietary Supplement: Coffee consumption

Interventions

Coffee consumptionDIETARY_SUPPLEMENT

Coffee is consumed before cognitive tests. One cup of instant coffee with 75 mg of caffeine or 0 mg caffeine and will be prepared with 150-200 mL of hot water.

Also known as: Instant coffee
CaffeineCoffee without caffeine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy as assessed by the:
  • health and lifestyle questionnaire
  • Adult age (\>18y)
  • Able to perform computerized tests
  • Voluntary participation
  • Having given written informed consent
  • Willing to comply with the study procedures
  • Moderate caffeine users
  • Able to use a desk top or laptop with internet access at home
  • Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data 10 Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned

You may not qualify if:

  • Having a history of medical or surgical events that may significantly affect the study outcome, including attention (ADHD etc), psychological or psychiatric disorders
  • Physical, mental or practical limitations in using computerized systems
  • Use of concomitant medication including medication known for its effects on mood and/or attention (anti-depressives, sleep medication, etc)
  • Alcohol consumption \> 28 units/week for males and \> 21 units (drinks)/week for females
  • Personnel of TNO of location Zeist or of location Soesterberg, their partner and their first and second-generation relatives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TNO

Zeist, Utrecht, 3704HE, Netherlands

Location

Related Publications (1)

  • Pasman WJ, Boessen R, Donner Y, Clabbers N, Boorsma A. Effect of Caffeine on Attention and Alertness Measured in a Home-Setting, Using Web-Based Cognition Tests. JMIR Res Protoc. 2017 Sep 7;6(9):e169. doi: 10.2196/resprot.6727.

    PMID: 28882811DERIVED

Study Officials

  • Wilrike Pasman, PhD

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 12, 2013

First Posted

February 13, 2014

Study Start

November 1, 2013

Primary Completion

December 1, 2013

Study Completion

April 1, 2014

Last Updated

May 9, 2014

Record last verified: 2014-05

Locations

NL(1)