NCT02061982

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: TNO · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• At Home Setting
• Coffee With or Without Caffeine

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-11-01
• Primary completion: 2013-12-01
• Completion: 2014-04-01
• First posted: 2014-02-13
• Last updated: 2014-05-09

Locations

1 site across 1 country: Netherlands