UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023777
Receipt number R000027387
Scientific Title A study for evaluating the effect of the intake of a food containing malted rice on retaining moisture of the skin in adult female.
Date of disclosure of the study information 2017/11/25
Last modified on 2017/02/23 11:49:09

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Basic information

Public title

A study for evaluating the effect of the intake of a food containing malted rice on retaining moisture of the skin in adult female.

Acronym

A study for the effect of a food containing malted rice on skin dry.

Scientific Title

A study for evaluating the effect of the intake of a food containing malted rice on retaining moisture of the skin in adult female.

Scientific Title:Acronym

A study for the effect of a food containing malted rice on skin dry.

Region

Japan


Condition

Condition

N/A

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study examines effects of a food containing malted rice on skin dry.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Skin moisture content

Key secondary outcomes

Transepidermal water loss
Questionnaire


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of the test products containing malted rice (once per a day 8 weeks).

Interventions/Control_2

Ingestion of the placebo (once per a day 8 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

64 years-old >=

Gender

Female

Key inclusion criteria

(1)Females from 20 to 64 years of age.
(2)Subjects who are anxious about skin dryness.

Key exclusion criteria

(1)Subjects who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements which may influence skin.
(2)Subjects who has treated cosmetic care.
(3)Subjects who has treated cosmetic care except for measuring sites, or hormonal therapy for one year.
(4)Subjects who got a facial, a wash-rag, lost hair on measuring sites for one month ago, or plans these actions.
(5)Subjects who a long period of time of work and leisure in the outdoors, the sunburn in the exercise for until one month plans these actions.
(6)Subjects who washes the body using a nylon towel which provides strong skin irritation.
(7)Subjects who has the wound or inflammatory disease affecting the measuring skin.
(8)Subjects who has being excepted to be developed the allergy symptoms on skin.
(9)Subjects who feels to trouble by rough skin around a menstruates.
(10)Subjects who is employed on a pre-dawn shift or on night duty more than 2 times.
(11)Subjects who is planned to go overseas.
(12)Subjects who has asthma or the possibility of asthma.
(13)Subjects who has treatment or a history of serious disease or affecting a secretion of sex hormones.
(14)Subjects having possibilities for emerging allergy related to the study.
(15)Subjects having possibilities for emerging allergy related to the study.
(16)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on screening test.
(17)Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study.
(18)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
(19)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
(20)Subjects judged as unsuitable for the study by the investigator for other reasons.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shogo Koike

Organization

Marukome Co.,Ltd

Division name

Marketing Department

Zip code


Address

Amori, 883, Nagano-shi, Nagano

TEL

026-226-0165

Email

s_koike@marukome.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Noriko Watanabe

Organization

TTC Co.,Ltd

Division name

Clinical Research Planning Department

Zip code


Address

Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL


Email

n.watanabe@ttc-tokyo.co.jp


Sponsor or person

Institute

TTC Co.,Ltd

Institute

Department

Personal name



Funding Source

Organization

Marukome Co.,Ltd

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



Other administrative information

Date of disclosure of the study information

2017 Year 11 Month 25 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

2016 Year 07 Month 28 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 29 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

2016 Year 08 Month 26 Day

Last modified on

2017 Year 02 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027387


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name