At Home SettingPhase 2/3NCT02061982
Do It Yourself (DIY) Coffee Study; Test Effect of Coffee on Cognition in an at Home Setting
A Phase 2/3 study testing Coffee consumption in people with At Home Setting and Coffee With or Without Caffeine, run by TNO at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- At Home Setting, Coffee With or Without Caffeine
- What is being tested?
- Coffee consumption
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2013to Apr 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy as assessed by the:
- health and lifestyle questionnaire
- Adult age (>18y)
- Able to perform computerized tests
- Voluntary participation
- Having given written informed consent
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- At Home Setting, Coffee With or Without Caffeine
- Being tested
- Coffee consumption
- Keywords
- Do It Yourself (DIY), Caffeine, Cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coffee consumptionDietary supplement
Also called Instant coffee
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.
| Study group | Role | What they receive |
|---|---|---|
| Caffeine | Experimental | Instant coffee with or without caffeine will be provided Receives: Dietary Supplement: Coffee consumption |
| Coffee without caffeine | Placebo comparator | Coffee without caffeine Receives: Dietary Supplement: Coffee consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1.5 hour
Secondary outcomes (1)
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)).
Measured: 1.5 hour on four test days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for At Home SettingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- TNO
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, W.J. Pasman, TNO
- Investigators
- Wilrike Pasman, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061982
- Sponsor's protocol ID
- P9568
- Status last verified
- May 2014
- First submitted
- 12 Nov 2013
- Last updated
- 9 May 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 28882811
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02061982
- Acronym / sponsor ID
- P9568
- Conditions
- At Home Setting, Coffee With or Without Caffeine
- Keywords
- Do It Yourself (DIY), Caffeine, Cognition
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- TNOUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 13 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine | Experimental | Dietary Supplement: Coffee consumptionInstant coffee with or without caffeine will be provided |
| Coffee without caffeine | Placebo comparator | Dietary Supplement: Coffee consumptionCoffee without caffeine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy as assessed by the:
- Adult age (>18y)
- Able to perform computerized tests
- Voluntary participation
- Having given written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coffee consumptionAlso: Instant coffeeCoffee 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. | Dietary supplement | Caffeine, Coffee without caffeine |
Primary outcome
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.
1 secondary outcome
The effect of coffee with and without caffeine on alertness and attention
Time frame: 1.5 hour on four test days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2014.
- Derived from this study: PubMed 28882811Pasman 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.
Related trials for At Home Setting
Not yet recruiting
Testing Settings of NovaResp's cMAP® Software During Home PAP Therapy
Obstructive Sleep Apnea
RecruitingObservational study
Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing
Early Risk Screening for Sleep Disordered Breathing in a Dental Setting, Sleep Disordered Breathing (SDB)
Recruiting
Comparison of the Efficacy of Transcranial Direct Current Stimulation at Home Versus in Hospital Settings in Patients With Depressive Episodes
Depression
Recruiting
Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by Participants
End Stage Kidney Disease
Recruiting
Exoskeleton Training at Home to Assist Participants With Spinal Cord Injuries to Perform Ambulatory Functions.
Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilrike Pasman, PhD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Coffee consumption in people with At Home Setting and Coffee With or Without Caffeine, run by TNO at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate at home tests with controlled tests in experiment in metabolic ward (time frame: 1.5 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02061982, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2014.