UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029571 |
|---|---|
| Receipt number | R000033740 |
| Scientific Title | Validation study of the anti-fatigue effects of imidazole dipeptide for the person performing daily exercise |
| Date of disclosure of the study information | 2017/10/17 |
| Last modified on | 2018/02/23 14:17:13 |
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Basic information
Public title
Validation study of the anti-fatigue effects of imidazole dipeptide for the person performing daily exercise
Acronym
Validation study of the anti-fatigue effects of imidazole dipeptide
Scientific Title
Validation study of the anti-fatigue effects of imidazole dipeptide for the person performing daily exercise
Scientific Title:Acronym
Validation study of the anti-fatigue effects of imidazole dipeptide
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 imidazole dipeptide.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
performance test (shot of tennis) 2weeks after
Key secondary outcomes
POMS2-AS
"Jikaku-sho Shirabe"(Visual Analog Scale)
Kinetic eyesight
Pulse wave
Heart rate
Blood flow
Pulse
Oxygen saturation concentration
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 intake of the control product(2weeks)
Interventions/Control_2
Oral intake of the test product(processed food containing imidazole dipeptide)(2weeks)
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Male and female healthy adults from 20 to 60 years old
2)Individuals who are without chronic illness or disease under treatment
3)Individuals who obtain written consent from the person himself(herself)
Key exclusion criteria
1)Individuals who are sensitive to test products, the others food or medicine
2)Individuals who have a habit to ingest medicine, health foods or supplements that affects research results
3)Individuals who are pregnant or planning to become pregnant, and individuals who are breastfeeding
4)Individuals who have a history of serious heart disease, hepatopathy, kidney damage and digestive organ
5)Individuals who have been pointed out in the past abnormal ECG (arrhythmia etc.)
6)Alcohol drinkers
7)Individuals whose eating habits are extremely irregular and individuals whose life rhythms are irregular
8)Individuals who have being participate in other clinical research, individuals who are planned to participate in other clinical research within 4 weeks after the end of the study, or individuals who are planned to participate in other clinical study after informed consent for the current study
9)Individuals who were judged inappropriate for the study by tennis coach
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori Takahashi |
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
yo-takahashi@maruha-nichiro.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asami Michitatsu |
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
a-michitatsu@maruha-nichiro.co.jp
Sponsor or person
Institute
Maruha Nichiro Corporation
Institute of Next Generation SMILE
WINFrontier Co., Ltd.
CPCC Company Limited
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
| 2017 | Year | 10 | Month | 17 | 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
| 2017 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 16 | Day |
Last modified on
| 2018 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033740
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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