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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Evaluate at home tests with controlled tests in experiment in metabolic ward
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy as assessed by the:
- •health and lifestyle questionnaire
- •Adult age (>18y)
- •Able to perform computerized tests
- •Voluntary participation
- •Having given written informed consent
- •Willing to comply with the study procedures
- •Moderate caffeine users
- •Able to use a desk top or laptop with internet access at home
- •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
- •Having a history of medical or surgical events that may significantly affect the study outcome, including attention (ADHD etc), psychological or psychiatric disorders
- •Physical, mental or practical limitations in using computerized systems
- •Use of concomitant medication including medication known for its effects on mood and/or attention (anti-depressives, sleep medication, etc)
- •Alcohol consumption > 28 units/week for males and > 21 units (drinks)/week for females
- •Personnel of TNO of location Zeist or of location Soesterberg, their partner and their first and second-generation relatives
Arms & Interventions
Caffeine
Instant coffee with or without caffeine will be provided
Intervention: Coffee consumption (Dietary Supplement)
Coffee without caffeine
Coffee without caffeine
Intervention: Coffee consumption (Dietary Supplement)
Outcomes
Primary Outcomes
Evaluate at home tests with controlled tests in experiment in metabolic ward
Time Frame: 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 Outcomes
- The effect of coffee with and without caffeine on alertness and attention(1.5 hour on four test days)
Investigators
W.J. Pasman
Principal Investigator
TNO