UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036579
Receipt number R000041670
Scientific Title Effects of freeze-dried amazake on women's skin and gut
Date of disclosure of the study information 2019/04/24
Last modified on 2021/01/05 10:10:40

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effects of freeze-dried amazake on women's skin and gut

Acronym

Freeze-dried amazake study

Scientific Title

Effects of freeze-dried amazake on women's skin and gut

Scientific Title:Acronym

Freeze-dried amazake study

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effects of consuming freeze-dried amazake on healthy women's skin and daily life.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Skin condition

Key secondary outcomes

VAS questionnaire, Measurement of microflora


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Test group
Duration: 1 month, 2 times a day
Test material: Freeze-dried amazake

Interventions/Control_2

Placebo group:
Duration: 1 month, 2 times a day
Test material: Freeze-dried placebo

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

40 years-old <=

Age-upper limit

69 years-old >=

Gender

Female

Key inclusion criteria

Healthy women from 40 to 69 years old
Subjects who cares about rough skin with constipation
Subjects who can visit the examination place on a fixed schedule
Subjects who can cooperate with weight measurement, a questionnaire and skin measurement at the examination place
Subjects who can cooperate with feces examination at home
Subjects who can intake test food dissolved with hot water etc., twice a day during the examination
Subjects who can fill up the examination record everyday
Subjects who are careful about alcohol content in amazake (less than 0.2%)

Key exclusion criteria

Subjects who have food allergy
Subjects who are pregnant or lactating, or planned to become pregnant in the near future
Subjects who have previously taken a supplement etc. and have felt unwell
Subjects who are under medical treatment with illness or injury (except subjects who are under stable hypertension treatment)
Subjects who take supplements in the past 1 month
Subjects who are abnormally weak to alcohol

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Masahiko
Middle name
Last name Sai

Organization

MORINAGA & CO., LTD.

Division name

Health Science Research Center, R&D Institute

Zip code

230-8504

Address

2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama

TEL

045-571-298

Email

m-sai-ia@morinaga.co.jp


Public contact

Name of contact person

1st name Hiroko
Middle name
Last name Uchida

Organization

MORINAGA & CO., LTD.

Division name

Health Science Research Center, R&D Institute

Zip code

230-8504

Address

2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama

TEL

070-3864-8664

Homepage URL


Email

h-uchida-ji@morinaga.co.jp


Sponsor or person

Institute

MORINAGA & CO., LTD.

Institute

Department

Personal name



Funding Source

Organization

Morinaga & 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

Hibiya Skin Clinic.

Address

1-7-1,Yuraku-cho, Chiyoda-ku,Tokyo,Japan

Tel

03-5220-1220

Email

Hibiya-skin@orchid.plala.or.jp


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

2019 Year 04 Month 24 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

20

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

We could not submit a paper, because we did not register in UMIN.

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

Main results already published

Date of protocol fixation

2014 Year 10 Month 03 Day

Date of IRB

2014 Year 10 Month 10 Day

Anticipated trial start date

2014 Year 10 Month 14 Day

Last follow-up date

2014 Year 12 Month 22 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 04 Month 23 Day

Last modified on

2021 Year 01 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041670


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name