The current study is aimed to evaluate the procedure of performing a non invasive intervention study by subjects themselves performing the tests at home.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
aandacht en alertheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 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.
Secondary outcome
Adverse events
Background summary
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. TNO started a project to design a randomized double blind
study, in which parameters will be measured in the at-home setting instead of
in a clinical setting
Study objective
The current study is aimed to evaluate the procedure of performing a non
invasive intervention study by subjects themselves performing the tests at
home.
Study design
The study is designed as a randomized placebo-controlled double blind crossover
study.
Intervention
Subjects have to consume a cup of coffee after an overnight fast. Coffee will
be prepared from a powder coffee containing either regular coffee or decaf
coffee.
Study burden and risks
We do not foresee any risk. The coffee products are commercially available and
therefore prepared according to food laws. The recruited subjects are habitual
coffee drinkers, and the studied dose is a normal portion of caffeine.
Utrechtseweg 48
Zeist 3704 HE
NL
Utrechtseweg 48
Zeist 3704 HE
NL
Listed location countries
Age
Inclusion criteria
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. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data
9. 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 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. TNO personnel location Zeist or Soesterberg, their partner and their first and second-generation relatives
6. Not having a general practitioner
7. Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health. For example, findings at health and lifestyle questionnaire interview, and eventual adverse events communicated to and from their general practitioner
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL45382.028.13 |