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Completed

NCT Number: NCT02061982

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

TNO

Zeist, Utrecht, 3704HE, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Coffee Consumption

Dietary 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.

Other names: Instant coffee

Primary outcomes

  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 outcomes

  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)).

Sponsors and collaborators

Lead sponsor

TNO

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Feb 13, 2014
Registry last updated
May 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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