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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

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.

Condition or disease Intervention/treatment Phase
At Home Setting Coffee With or Without Caffeine Dietary Supplement: Coffee consumption Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Experimental: Caffeine
Instant coffee with or without caffeine will be provided
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

Placebo Comparator: Coffee without caffeine
Coffee without caffeine
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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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)).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061982


Locations
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Netherlands
TNO
Zeist, Utrecht, Netherlands, 3704HE
Sponsors and Collaborators
TNO
Investigators
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Principal Investigator: Wilrike Pasman, PhD Principal Investigator

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: W.J. Pasman, Principal Investigator, TNO
ClinicalTrials.gov Identifier: NCT02061982     History of Changes
Other Study ID Numbers: P9568
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: May 2014

Keywords provided by W.J. Pasman, TNO:
Do It Yourself (DIY)
Caffeine
Cognition

Additional relevant MeSH terms:
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Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents