UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022743 |
|---|---|
| Receipt number | R000025249 |
| Scientific Title | validation study of the anti-fatigue effects of Salmon extra containing anserine for the person performing daily exercise |
| Date of disclosure of the study information | 2016/07/19 |
| Last modified on | 2016/08/17 16:32:29 |
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Basic information
Public title
validation study of the anti-fatigue effects of Salmon extra containing anserine for the person performing daily exercise
Acronym
the anti-fatigue effects of Salmon extra containing anserine
Scientific Title
validation study of the anti-fatigue effects of Salmon extra containing anserine for the person performing daily exercise
Scientific Title:Acronym
the anti-fatigue effects of Salmon extra containing anserine
Region
| Japan |
Condition
Condition
validation of the anti-fatigue effects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This test is intended to validate the anti-fatigue effects of the person performing daily exercise by intake of salmon extract containing anserine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
performance test (shot of tennis) 2week after
Key secondary outcomes
Obstructive Sleep Apnoea(OSA)
POMS
Pulse wave
Heart rate
amylase activating in saliva
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of the control product(2week)
Interventions/Control_2
Oral ingestion of the test product(jelly
containing anserine)(2week)
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Continued tennis rally is more than 10 times
Key exclusion criteria
1) Individuals judged inappropriate for the study by the principal
2) Individuals using medical products( sleeping drug)
3) Individuals who had a habit to ingest health foods or supplements(Sleep improvement functional food)
4) Individuals who are sensitive to test products
5) Individuals who have a history of serious hepatopathy, kidney damage, heart disease
6) Smoker
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Itao |
Organization
WIN Frontier Co., Ltd.
Division name
WIN Frontier Co., Ltd.
Zip code
Address
247 Shin-Yurakucho Building, 1-12-1 Yurakucho, Chiyoda-ku, Tokyo, 100-0006 Japan
TEL
03-6266-2050
kenichi.itao@winfrontier.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Konishi |
Organization
Maruha Nichiro Corporation
Division name
Central Research Institute
Zip code
Address
16-2, Wadai, Tsukuba-City, Ibaraki, 300-4295 Japan
TEL
029-864-6712
Homepage URL
t-konishi@maruha-nichiro.co.jp
Sponsor or person
Institute
WIN Frontier Co., Ltd.
Maruha Nichiro Corporation
Specified Nonprofit Corporation Palm International Shonan
Institute
Department
Personal name
Funding Source
Organization
Maruha Nichiro Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
| 2016 | Year | 07 | 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
| 2016 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 15 | Day |
Last modified on
| 2016 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025249
| 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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| Registered date | File name |
