Clinical trial NCT02061982: Do It Yourself (DIY) Coffee Study; Test Effect of Coffee on Cognition in an at Home Setting
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: At Home Setting
Coffee With or Without Caffeine
Keywords: Do It Yourself (DIY)
Caffeine
Cognition
Lead sponsor: TNO
Sponsor class: OTHER
First posted: 2014-02-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Evaluate at home tests with controlled tests in experiment in metabolic ward
timeFrame: 1.5 hour
Secondary outcomes:
measure: The effect of coffee with and without caffeine on alertness and attention
timeFrame: 1.5 hour on four test days
Other outcomes:
Locations:
city: Zeist
country: Netherlands
facility: TNO
state: Utrecht
Study officials:
affiliation: Principal Investigator
name: Wilrike Pasman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.