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Caffeine's Effect on Attention

Sponsor
Nestlé (Industry)
Overall Status
Completed
CT.gov ID
NCT02264561
Collaborator
(none)
71
Enrollment
1
Location
2
Arms
3
Duration (Months)
23.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether caffeine improves attention.

Condition or Disease Intervention/Treatment Phase
  • Other: Food
  • Other: Food
 N/A

Detailed Description

Single centre single dose cross-over, placebo-controlled, double blind, randomized trial with two treatment conditions : caffeine and placebo

Study Design

Study Type:
Interventional
Actual Enrollment :
71 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title:
The Effect of Caffeine on Attention
Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Mannitol administered at visit 1 and at visit 2

Other: Food
Active group
Other Names:
  • Caffeine

    • Other: Food
    Control group
    Other Names:
  • Placebo

    		•
    Active Comparator: caffeine

    caffeine administered at visit 1 and at visit 2

    Other: Food
    Active group
    Other Names:
  • Caffeine

    • Other: Food
    Control group
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Attention test: milliseconds and index of stimulus sensitivity [duration 10 days from screening to last visit (V2)]

    Secondary Outcome Measures

    1. Central Nervous System :response time. [duration: 10 days from screening to last visit (V2)]

    2. Mood measures: Visual Analog scale. [duration 10 days from screening to last visit V2]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    Healthy male and female Aged 40-60 years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center for Human Drug Research Leiden CL Netherlands 2333

    Sponsors and Collaborators

    • Nestlé

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nestlé
    ClinicalTrials.gov Identifier:
    NCT02264561
    Other Study ID Numbers:
    • 14.12.NRC
    First Posted:
    Oct 15, 2014
    Last Update Posted:
    Apr 8, 2015
    Last Verified:
    Apr 1, 2015
    Additional relevant MeSH terms:
    Caffeine

    Study Results

    No Results Posted as of Apr 8, 2015