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Do It Yourself (DIY) Coffee Study; Test Effect of Coffee on Cognition in an at Home Setting

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ClinicalTrials.gov Identifier: NCT02061982
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
W.J. Pasman, TNO

Tracking Information
First Submitted Date  ICMJE November 12, 2013
First Posted Date  ICMJE February 13, 2014
Last Update Posted Date May 9, 2014
Study Start Date  ICMJE November 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
Evaluate at home tests with controlled tests in experiment in metabolic ward [ Time Frame: 1.5 hour ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02061982 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
The effect of coffee with and without caffeine on alertness and attention [ Time Frame: 1.5 hour on four test days ]
The effectiveness of the at home setting will partly be evaluated by the results found with the at home data on cognitive performance (reaction time (msec) and accuracy (% correct)).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Do It Yourself (DIY) Coffee Study; Test Effect of Coffee on Cognition in an at Home Setting
Official Title  ICMJE A Non Invasive Intervention Study Performed by Subjects Themselves at Home; Evaluation of Study Infrastructure by Measuring the Effect of Caffeine on Attention and Alertness
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.
Detailed Description

There is increasing interest in the general public in measuring health parameters at home, instead of in a medical setting. Many tests for measuring health parameters are commonly available in drug stores as well as online. When structured, this trend may also be used for performing a randomized intervention trial.

The current study is aimed to evaluate the procedure of performing a non invasive intervention study by subjects themselves performing the tests at home.

The study is designed as a randomized, placebo-controlled, double blind, crossover study.

Subjects have to consume a cup of coffee after an overnight fast. Coffee will be prepared from instant coffee containing either regular coffee or decaff coffee. Each intervention will be given twice.

Effects on alertness and attention will be established by three computerized tests provided by Quantified Mind. The tests will be performed by the subjects at t=0 (baseline, prior to coffee consumption) and t=1h, one hour after coffee consumption, in one go. Each test will be performed during 5 minutes. During the training session the participants will be instructed to get acquainted with the task.

The evaluation of the study concerns the effect of caffeine in the at home setting versus published results, as well as reproducibility of the results.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • At Home Setting
  • Coffee With or Without Caffeine
Intervention  ICMJE Dietary Supplement: Coffee consumption
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.
Other Name: Instant coffee
Study Arms  ICMJE
  • Experimental: Caffeine
    Instant coffee with or without caffeine will be provided
    Intervention: Dietary Supplement: Coffee consumption
  • Placebo Comparator: Coffee without caffeine
    Coffee without caffeine
    Intervention: Dietary Supplement: Coffee consumption
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2014)
70
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2014)
64
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy as assessed by the:

    • health and lifestyle questionnaire
  2. Adult age (>18y)
  3. Able to perform computerized tests
  4. Voluntary participation
  5. Having given written informed consent
  6. Willing to comply with the study procedures
  7. Moderate caffeine users
  8. Able to use a desk top or laptop with internet access at home
  9. 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

Exclusion Criteria:

  1. Having a history of medical or surgical events that may significantly affect the study outcome, including attention (ADHD etc), psychological or psychiatric disorders
  2. Physical, mental or practical limitations in using computerized systems
  3. Use of concomitant medication including medication known for its effects on mood and/or attention (anti-depressives, sleep medication, etc)
  4. Alcohol consumption > 28 units/week for males and > 21 units (drinks)/week for females
  5. Personnel of TNO of location Zeist or of location Soesterberg, their partner and their first and second-generation relatives
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02061982
Other Study ID Numbers  ICMJE P9568
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party W.J. Pasman, TNO
Study Sponsor  ICMJE TNO
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wilrike Pasman, PhD Principal Investigator
PRS Account TNO
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP