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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029621
Receipt No. R000033837
Scientific Title The effect of intake of specific food ingredients on human endurance
Date of disclosure of the study information 2017/10/19
Last modified on 2018/06/20

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Basic information
Public title The effect of intake of specific food ingredients on human endurance
Acronym The effect of intake of specific food ingredients on human endurance
Scientific Title The effect of intake of specific food ingredients on human endurance
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshihiko Minegishi
Organization Kao Corporation
Division name Biological Science Research
Zip code
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
1st name
Middle name
Last name Takahiro Hasumura
Organization Kao Corporation
Division name Biological Science Research
Zip code
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)

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 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

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 10 Month 18 Day
Date of IRB
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

Other
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

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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