AttentionNCT02264561
Caffeine's Effect on Attention
A study testing Food in people with Attention, run by Société des Produits Nestlé (SPN) at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether caffeine improves attention. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention
- What is being tested?
- Food
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2014to Dec 2014
- Phase
- Interventional
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Healthy male and female Aged 40-60 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Caffeine on Attention
The purpose of this study is to determine whether caffeine improves attention.
Read the detailed description
Single centre single dose cross-over, placebo-controlled, double blind, randomized trial with two treatment conditions : caffeine and placebo
- Conditions
- Attention
- Being tested
- Food
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoodOther
Also called Caffeine
Active group
FoodOther
Also called Placebo
Control group
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Mannitol administered at visit 1 and at visit 2 Receives: Other: Food |
| caffeine | Active comparator | caffeine administered at visit 1 and at visit 2 Receives: Other: Food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention test: milliseconds and index of stimulus sensitivity
Measured: duration 10 days from screening to last visit (V2)
Secondary outcomes (2)
Central Nervous System :response time.
Measured: duration: 10 days from screening to last visit (V2)
Mood measures: Visual Analog scale.
Measured: duration 10 days from screening to last visit V2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AttentionStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264561
- Sponsor's protocol ID
- 14.12.NRC
- Status last verified
- Apr 2015
- First submitted
- 24 Sep 2014
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Caffeine on Attention
- ClinicalTrials.gov ID
- NCT02264561
- Acronym / sponsor ID
- 14.12.NRC
- Conditions
- Attention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Oct 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.
The purpose of this study is to determine whether caffeine improves attention.
Detailed description
Single centre single dose cross-over, placebo-controlled, double blind, randomized trial with two treatment conditions : caffeine and placebo
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: FoodMannitol administered at visit 1 and at visit 2 |
| caffeine | Active comparator | Other: Foodcaffeine administered at visit 1 and at visit 2 |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| FoodAlso: CaffeineActive group | Other | Placebo, caffeine |
| FoodAlso: PlaceboControl group | Other | Placebo, caffeine |
Primary outcome
Attention test: milliseconds and index of stimulus sensitivity
Time frame: duration 10 days from screening to last visit (V2)
2 secondary outcomes
Central Nervous System :response time.
Time frame: duration: 10 days from screening to last visit (V2)
Mood measures: Visual Analog scale.
Time frame: duration 10 days from screening to last visit V2
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 8 Apr 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food in people with Attention, run by Société des Produits Nestlé (SPN) 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?
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 8 Apr 2015. 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.
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?
Attention test: milliseconds and index of stimulus sensitivity (time frame: duration 10 days from screening to last visit (V2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2015.