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

At Home Setting Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02061982
• Other study ID #: P9568
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 12, 2013
• Last updated: May 8, 2014
• Start date: November 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: TNO
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• At Home Setting
• Coffee With or Without Caffeine

Intervention

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.

Locations

Country	Name	City	State
Netherlands	TNO	Zeist	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
TNO

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No