UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of intake of specific food ingredients on human endurance
Title of the study (Brief title)	The effect of intake of specific food ingredients on human endurance
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 effect of intake of specific food ingredients on 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 weeks).
Key secondary outcomes	Blood component variation on the last day of each period.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake foods (supplements)/drinks containing specific food ingredients for 2 weeks and exercise on the final day.->Washout more than 2 days.->Intake foods (supplements)/drinks not containing specific food ingredients for 2 weeks and exercise on the final day.
Interventions/Control_2	Intake foods (supplements)/drinks not containing specific food ingredients for 2 weeks and exercise on the final day. ->Washout more than 2 days.->Intake foods (supplements)/drinks containing specific food ingredients for 2 weeks 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 can receive physical fitness measurement 2.A person with exercise habits of about once a month 3.A person who is not prohibited from exercising by doctors 4.A person who is able to comply with the instructions of the person in charge of research and research and the medical staff involved in this 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 thyroid function 5.A person with abnormal sugar / lipid metabolism 6.A person receiving treatment with hyperlipemia medication or hyperglycemia treatment 7.A person who drinks alcohol (alcohol equivalent of 20 g / day or more) 8.A person who had weight changes of +/- 3 kg or more during the 3 months before the start of the test food ingredients 9.A person who has a history of hypersensitivity with respect to the components of the test food 10.Food allergy to eggs, milk, wheat, beef, soybean, chicken, pork, seafood, ingredients derived from gelatin etc 11.A person who is ingesting foods for specified health use, supplements, diet foods and who can not withhold intake during the test period 12.A person who drinks more than 6 cups of tea, coffee, tea on a daily basis 13.A person with severe anemia 14.A person who currently has trouble in the lower limb exercise machine, or who had it within the past year 15.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) 16.A person who is prohibited from exercising or intense movement from a doctor
Target sample size	10

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

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

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)

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	2017 Year 10 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 18 Day
Anticipated trial start date	2017 Year 10 Month 20 Day
Last follow-up date	2017 Year 12 Month 29 Day
Date of closure to data entry	2018 Year 03 Month 30 Day
Date trial data considered complete	2018 Year 05 Month 31 Day
Date analysis concluded	2018 Year 09 Month 30 Day

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

Management information
Registered date	2017 Year 10 Month 19 Day
Last modified on	2018 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033837