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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031484
Receipt No. R000035940
Scientific Title Validation of blood kinetics by intake of test food.
Date of disclosure of the study information 2018/03/01
Last modified on 2018/08/28

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Basic information
Public title Validation of blood kinetics by intake of test food.
Acronym Validation of blood kinetics by intake of test food.
Scientific Title Validation of blood kinetics by intake of test food.
Scientific Title:Acronym Validation of blood kinetics by intake of test food.
Region
Japan

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

Objectives
Narrative objectives1 To clarify blood dynamics of amino acids after ingesting test foods.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Blood amino acid concentration.
Key secondary outcomes None.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
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 of test food (control). Establish at least 3 days washout period. Intake of test food (active).
Interventions/Control_2 Intake of test food (active). Establish at least 3 days washout period. Intake of test food (control).
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
39 years-old >=
Gender Male
Key inclusion criteria None
Key exclusion criteria -A person who has had severe diseases or the past illness on liver, kidney, heart, lung, digestive organs, blood, endocrine, nerve and metabolic system.
-A person who has had dietary allergy.
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 +81-285-68-7817
Email minegishi.yoshihiko@kao.com

Public contact
Name of contact person
1st name
Middle name
Last name Kotaro Tamura
Organization Kao Corporation
Division name Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7687
Homepage URL
Email tamura.kotaro@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
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
2018 Year 03 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
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 02 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 26 Day
Last modified on
2018 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035940

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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