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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02264561
Other study ID # 14.12.NRC
Secondary ID
Status Completed
Phase N/A
First received September 24, 2014
Last updated April 7, 2015
Start date September 2014
Est. completion date December 2014

Study information

Verified date April 2015
Source Nestlé
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 71
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 60 Years
Eligibility Healthy male and female Aged 40-60 years

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Other:
Food
Active group
Food
Control group

Locations

Country Name City State
Netherlands Center for Human Drug Research Leiden CL

Sponsors (1)

Lead Sponsor Collaborator
Nestlé

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Attention test: milliseconds and index of stimulus sensitivity duration 10 days from screening to last visit (V2) No
Secondary Central Nervous System :response time. duration: 10 days from screening to last visit (V2) No
Secondary Mood measures: Visual Analog scale. duration 10 days from screening to last visit V2 No
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