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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029571
Receipt No. 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

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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
Email 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
Email a-michitatsu@maruha-nichiro.co.jp

Sponsor
Institute Maruha Nichiro Corporation
Institute of Next Generation SMILE
WINFrontier Co., Ltd.
CPCC Company Limited
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033740

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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