- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02264561
Caffeine's Effect on Attention
April 7, 2015 updated by: Société des Produits Nestlé (SPN)
The Effect of Caffeine on Attention
The purpose of this study is to determine whether caffeine improves attention.
Study Overview
Detailed Description
Single centre single dose cross-over, placebo-controlled, double blind, randomized trial with two treatment conditions : caffeine and placebo
Study Type
Interventional
Enrollment (Actual)
71
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
CL
-
Leiden, CL, Netherlands, 2333
- Center for Human Drug Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Healthy male and female Aged 40-60 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
Mannitol administered at visit 1 and at visit 2
|
Active group
Other Names:
Control group
Other Names:
|
|
Active Comparator: caffeine
caffeine administered at visit 1 and at visit 2
|
Active group
Other Names:
Control group
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Attention test: milliseconds and index of stimulus sensitivity
Time Frame: duration 10 days from screening to last visit (V2)
|
duration 10 days from screening to last visit (V2)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Central Nervous System :response time.
Time Frame: duration: 10 days from screening to last visit (V2)
|
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
|
duration 10 days from screening to last visit V2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
September 24, 2014
First Submitted That Met QC Criteria
October 9, 2014
First Posted (Estimate)
October 15, 2014
Study Record Updates
Last Update Posted (Estimate)
April 8, 2015
Last Update Submitted That Met QC Criteria
April 7, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14.12.NRC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.