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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000030154
Receipt No. R000034441
Scientific Title Effect of food-derived powder on physical function
Date of disclosure of the study information 2017/12/15
Last modified on 2018/05/29

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Basic information
Public title Effect of food-derived powder on physical function
Acronym Effect of food-derived powder on physical function
Scientific Title Effect of food-derived powder on physical function
Scientific Title:Acronym Effect of food-derived powder on physical function
Region
Japan

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

Objectives
Narrative objectives1 To elucidate the effects of diet containing food-derived powder on physical function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of the cognitive function after eating of diet containing food-derived powder once a day for 2 weeks
Key secondary outcomes Evaluation of the body composition, motor function, body temperature and blood test after eating of diet containing food-derived powder once a day for 2 weeks

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 Prevention
Type of intervention
Food
Interventions/Control_1 Intake diet containing food-derived powder once a day for 2 weeks->Washout more than 2 weeks->Intake placebo diet once a day for 2 weeks
Interventions/Control_2 Intake placebo diet once a day for 2 weeks->Washout more than 2 weeks->Intake diet containing food-derived powder once a day for 2 weeks
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
60 years-old >=
Gender Male
Key inclusion criteria 1)Subjects who are Japanese male.
Age >=20 and <=60 years.
2)Healthy males
3)Informed consent provided
4)Able to follow the instructions of the study team
Key exclusion criteria 1)Serious disorder
2)Regular hospital visit and medication intended to cure
3)Food allergy and suspected food allergy (Self-reported)
4)Subjects judged by the investigator/project leader to be ineligible for other reasons
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuya Mori
Organization Kao Corporation
Division name Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7769
Email mori.takuya@kao.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitaka Koga
Organization Kao Corporation
Division name Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7687
Homepage URL
Email koga.yoshitaka@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 12 Month 15 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 Terminated
Date of protocol fixation
2017 Year 10 Month 17 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 15 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
2017 Year 11 Month 28 Day
Last modified on
2018 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034441

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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