UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Validation study of the anti-fatigue effects of imidazole dipeptide for the person performing daily exercise
Title of the study (Brief title)	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	Yoshinori Takahashi
Organization	Maruha Nichiro Corporation
Division name	Central Research Institute
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	Asami Michitatsu
Organization	Maruha Nichiro Corporation
Division name	Central Research Institute
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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