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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035484
Receipt No. R000040424
Scientific Title The effect of intake of specific food ingredients on human endurance and fatigue
Date of disclosure of the study information 2019/05/01
Last modified on 2019/07/16

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Basic information
Public title The effect of intake of specific food ingredients on human endurance and fatigue
Acronym The effect of intake of specific food ingredients on human endurance and fatigue
Scientific Title The effect of intake of specific food ingredients on human endurance and fatigue
Scientific Title:Acronym The effect of intake of specific food ingredients on human endurance and fatigue
Region
Japan

Condition
Condition Healthy male adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the effects of the intake of tea catechins and amino acids on the blood component during exercise and human endurance
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Endurance on last day of each period (2 days)
Key secondary outcomes Blood component fluctuation, saliva component fluctuation, heart rate variability, rate of perceived exertion (RPE), visual analog scale (VAS) for fatigue at exercise test on last day of each period (2 days)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake of specific food ingredients for 2 days and exercise on the final day.->Washout more than 6 days.->Intake of placebo (without specific food ingredients) for 2 days and exercise on the final day.
Interventions/Control_2 Intake of placebo (without specific food ingredients) for 2 days and exercise on the final day.->Washout more than 2 weeks.->Intake of specific food ingredients for 2 days and exercise on the final day.
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
40 years-old >
Gender Male
Key inclusion criteria 1.A person who is healthy men of 20 to 39 years old
2.A person who can receive physical fitness measurement
3.A person with exercise habits of about once a week
4.A person who is able to comply with the instructions of the person in charge of research
5.A person who is in the Kao Tochigi Plant during the examination period and who can participate in the exam
Key exclusion criteria 1.A person with serious diseases such as liver, kidney, heart, lung, digestive organs, blood, endocrine system and metabolic system
2.Heart failure patients and a person with a history of myocardial infarction
3.A person who has a history of seizures based on nervous system diseases (loss of consciousness, coma, convulsions, etc.)
4.A person with abnormal sugar / lipid metabolism
5.A person who drinks alcohol (alcohol equivalent of 20 g / day or more)
6.Food allergy to wheat, eggs, milk, soybean, apple, pork, and, ingredients derived from gelatin etc
7.A person with severe anemia
8.A person who currently has trouble in the lower limb exercise machine, or who had it within the past 3 months
9.A person with lower physical strength / exercise ability (a person who can not do the bicycle pedaling movement of constant rhythm, a person who can not do persistence exercise for more than 20 minutes)
10.A person who is prohibited from exercising or intense movement from a doctor
Target sample size 16

Research contact person
Name of lead principal investigator
1st name Yoshihiko
Middle name
Last name Minegishi
Organization Kao Corporation
Division name Biological Science Research
Zip code 321-3497
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7817
Email minegishi.yoshihiko@kao.com

Public contact
Name of contact person
1st name Takahiro
Middle name
Last name Hasumura
Organization Kao Corporation
Division name Biological Science Research
Zip code 321-3497
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7817
Homepage URL
Email hasumura.takahiro@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao 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 Human Research Ethics Committee, Kao Corporation
Address 2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel +81-3-5630-9220
Email uesaka.toshio@kao.com

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 花王株式会社(栃木県)

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 01 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 8
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
2018 Year 10 Month 15 Day
Date of IRB
2018 Year 10 Month 15 Day
Anticipated trial start date
2019 Year 01 Month 08 Day
Last follow-up date
2019 Year 04 Month 09 Day
Date of closure to data entry
2019 Year 05 Month 09 Day
Date trial data considered complete
2019 Year 05 Month 09 Day
Date analysis concluded
2019 Year 06 Month 27 Day

Other
Other related information

Management information
Registered date
2019 Year 01 Month 08 Day
Last modified on
2019 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040424

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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