UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of food-derived powder on physical function
Title of the study (Brief title)	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	Takuya Mori
Organization	Kao Corporation
Division name	Biological Science Research
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	Yoshitaka Koga
Organization	Kao Corporation
Division name	Biological Science Research
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 10 Month 17 Day
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

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Publication of results	Unpublished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