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

Phase 2

Completed

• Conditions: At Home Setting; Coffee With or Without Caffeine
• Interventions: Dietary Supplement: Coffee consumption

• Registration Number: NCT02061982
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-12
• Primary Completion: 2013-12
• Study First Submitted QC: 2014-02-11
• Study First Posted: 2014-02-13
• Study Completion: 2014-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-08
• Last Update Posted: 2014-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Caffeine	Coffee consumption	Instant coffee with or without caffeine will be provided
Coffee without caffeine	Coffee consumption	Coffee without caffeine

Primary Outcome Measures

Name	Time	Method
Evaluate at home tests with controlled tests in experiment in metabolic ward	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

Name	Time	Method
The effect of coffee with and without caffeine on alertness and attention	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)).

Trial Locations

Locations (1)

TNO; 🇳🇱 Zeist, Utrecht, Netherlands