UMIN-CTR Clinical Trial

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