UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030154
Receipt number 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 17:34:19

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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 or person

Institute

Kao Corporation

Institute

Department

Personal name



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

Value
https://center6.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