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

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.

Study Overview

• Status: Completed
• Conditions: At Home Setting; Coffee With or Without Caffeine
• Intervention / Treatment: Dietary supplement: Coffee consumption

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht
    • Zeist, Utrecht, Netherlands, 3704HE
      • TNO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Instant coffee
Placebo Comparator: 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 Names: Instant coffee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate at home tests with controlled tests in experiment in metabolic ward	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.	1.5 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of coffee with and without caffeine on alertness and attention	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)).	1.5 hour on four test days

Collaborators and Investigators

• Sponsor: TNO
• Investigators: Principal Investigator: Wilrike Pasman, PhD, Principal Investigator

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: November 12, 2013
• First Submitted That Met QC Criteria: February 11, 2014
• First Posted (Estimate): February 13, 2014

Study Record Updates

• Last Update Posted (Estimate): May 9, 2014
• Last Update Submitted That Met QC Criteria: May 8, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Cognition; Caffeine; Do It Yourself (DIY)
• Other Study ID Numbers: P9568