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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003780
Receipt No. R000004553
Scientific Title EFFECT OF THE VITAMIN SUPPLEMENT DRINKS ON WORK PERFORMANCE - A DOUBLEBLIND, RANDOMIZED MULTIPLE DOSE TRIAL ON HEALTHY VOLUNTEERS
Date of disclosure of the study information 2010/06/19
Last modified on 2010/06/19

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Basic information
Public title EFFECT OF THE VITAMIN SUPPLEMENT DRINKS ON WORK PERFORMANCE - A DOUBLEBLIND, RANDOMIZED MULTIPLE DOSE TRIAL ON HEALTHY VOLUNTEERS
Acronym EFFECT OF THE VITAMIN SUPPLEMENT DRINKS ON WORK PERFORMANCE - A DOUBLEBLIND, RANDOMIZED MULTIPLE DOSE TRIAL ON HEALTHY VOLUNTEERS
Scientific Title EFFECT OF THE VITAMIN SUPPLEMENT DRINKS ON WORK PERFORMANCE - A DOUBLEBLIND, RANDOMIZED MULTIPLE DOSE TRIAL ON HEALTHY VOLUNTEERS
Scientific Title:Acronym EFFECT OF THE VITAMIN SUPPLEMENT DRINKS ON WORK PERFORMANCE - A DOUBLEBLIND, RANDOMIZED MULTIPLE DOSE TRIAL ON HEALTHY VOLUNTEERS
Region
Japan

Condition
Condition Healthy person
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this research was to clarify the effect of two kinds of energy drinks, one containing a vitamin compound, taurine, and caffeine and the other containing a vitamin compound, taurine, caffeine, and several botanical herb extracts, on work performance using cognitively subjective and objective indicators.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Subjective :.
selfreported questionnaires(Motivation, feeling of drowsiness, and fatigue) after 5 days administering.
Objective:
Kreapelin mental work test after 5 days administering.
Key secondary outcomes Fatigue visual analog scale after 5 days administering.
MFI20 after 5 days administering.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation NO
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1.a vitamin/taurine/caffeine(simple type) drink
2.a vitamin/taurine/caffeine/herb extracts(herb type) drink
Duration of treatment: 5 days
Total 10 days.
Interventions/Control_2 1.a vitamin/taurine/caffeine/herb extracts(herb type) drink
2.a vitamin/taurine/caffeine(simple type) drink
Duration of treatment: 5 days
Total 10 days.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
35 years-old >=
Gender Male and Female
Key inclusion criteria Male and female between 20 and 35 years of age inclusive, at the time of signing the informed consent.
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests.
Key exclusion criteria The subject has a known allergy to caffeine or alcohol.
The subject has a known hypersensitivity to medical drugs.
The subject usually uses simple or harbal type drinks.
Target sample size 14

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Emi Nakashima
Organization Keio University faculty of pharmacy
Division name Division of pharmaceutics
Zip code
Address 1-5-30, Shibakoen Minato-ku ,Tokyo
TEL 03-5400-2553
Email

Public contact
Name of contact person
1st name
Middle name
Last name Emi Nakashima
Organization Keio University faculty of pharmacy
Division name Division of pharmaceutics
Zip code
Address 1-5-30, Shibakoen Minato-ku ,Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Keio University faculty of pharmacy
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2010 Year 06 Month 19 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 07 Month 02 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2009 Year 08 Month 01 Day
Date of closure to data entry
2009 Year 09 Month 01 Day
Date trial data considered complete
2009 Year 09 Month 01 Day
Date analysis concluded
2010 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 06 Month 18 Day
Last modified on
2010 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004553

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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