UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011991 |
|---|---|
| Receipt number | R000014013 |
| Scientific Title | Influence of counceling intervention on the effectiveness of nutritions supplement drink in health vounteers measured with a brain monitoring system |
| Date of disclosure of the study information | 2013/10/10 |
| Last modified on | 2013/10/08 17:56:04 |
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Basic information
Public title
Influence of counceling intervention on the effectiveness of nutritions supplement drink in health vounteers measured with a brain monitoring system
Acronym
Influence of counceling intervention on the effectiveness of nutritions supplement drink
Scientific Title
Influence of counceling intervention on the effectiveness of nutritions supplement drink in health vounteers measured with a brain monitoring system
Scientific Title:Acronym
Influence of counceling intervention on the effectiveness of nutritions supplement drink
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the influence of counceling on the effectiveness of nutritions supplement drink in healthy volunteers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Subjective : multi-dimensional fatigue inventory-20 (MFI-20) Japanese version after treatment
Objective : blood flow in the inferior frontal cortex by near-infrared spectroscopy (NIRS) after treatment
Key secondary outcomes
Self-reported questionnaire (motivation, feeling of drowsiness and general fatigue)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
nutritions supplement drink
Interventions/Control_2
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
| 22 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
participants received a doctor's examination, physical examination (height, weight, temperature, and blood pressure), and general clinical evaluation (clinical chemistry, hematology, urinalysis)
Key exclusion criteria
not approved on healthy check
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nakashima Emi |
Organization
Keio University faculty of pharmacy
Division name
Division of pharmaceutics
Zip code
Address
105-8512 1-5-30 Shibakoen Minato-ku Tokyo Japan
TEL
03-5400-2660
nakashima-em@pha.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | isawa minae |
Organization
Keio University faculty of pharmacy
Division name
Division of pharmaceutics
Zip code
Address
105-8512 1-5-30 Shibakoen Minato-ku Tokyo Japan
TEL
03-5400-2660
Homepage URL
isawa-mn@pha.keio.ac.jp
Sponsor or person
Institute
Keio University faculty of pharmacy
Institute
Department
Personal name
Funding Source
Organization
Health and Labour Sciences Research Grant
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 10 | Month | 10 | 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
| 2012 | Year | 01 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2012 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 08 | Month | 05 | Day |
Date analysis concluded
| 2012 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 08 | Day |
Last modified on
| 2013 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014013
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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