UMIN-CTR Clinical Trial

Public title

Effect of Freeze-dried Amazake on the Defecation and the Condition of Skin in Healthy Adult Females.

Acronym

Effect of Amazake on the Defecation and the Condition of Skin.

Scientific Title

Effect of Freeze-dried Amazake on the Defecation and the Condition of Skin in Healthy Adult Females.

Scientific Title:Acronym

Effect of Amazake on the Defecation and the Condition of Skin.

Region

Japan

Condition

Verification of skin condition and bowel improvement effect of Amazake.

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Verification of skin condition and bowel improvement effect of Amazake.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Skin condition 5weeks after intervention.

Key secondary outcomes

Stool frequency, Consistency of stool, Volume of stool

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Period : 5weeks.
Test materials: Freeze dried Amazake.
Does: 2 portions for a day.

Interventions/Control_2

Period : 5weeks.
Test materials: Freeze dried placebo food.
Does: 2 portions for a day.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

35

years-old

<=

Age-upper limit

49

years-old

>=

Gender

Female

Key inclusion criteria

1.Premenopausal healthy female ranging in age from 35 to 49 years.
2.BMI is from 18.5 to 25.0 kg/m^2
3.Subjects with the tendency of the coprostasis and concern about rough skin.
4.Sleep life rhythm is constant as possible.
5.Subjects who can have an examination in a designated day
6.Subjects who can cooperate with the weight measurement, the skin measurement, a questionnaire at a university.
7.Subjects who can intake test food in hot water twice a day in the morning and evening during the examination period.
8.Subjects can record a life diary everyday.
9.The test food contains less than 0.2% alcohol (about 100 mL). Subjects who can stop driving of a car.

Key exclusion criteria

1.Subjects with food allergies.
2.Subjects have habitual smoke within 6 months.
3.Pregnant patients or patients who are probably pregnant.
4.Subjects using oral contraceptives.
5.Subjects having medical history of physical disorders when intake supplements and/or diet foods.
6.Subjects who taking any kind of medicine and/or food for specified health uses and/or nutritional supplements within 1 month.
7.Subjects who can't drink alcohol.
8.Subjects have allergies to pollen.

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Maeda, Kazuhisa

Organization

Tokyo University of Technology

Division name

School of Bioscience and Biotechnology

Zip code

Address

1404-1 Katakuramachi, Hachioji

TEL

042-637-2442

Email

kmaeda@stf.teu.ac.jp

Name of contact person

1st name
Middle name
Last name	Inagaki, Hiroyuki

Organization

MORINAGA & CO.,Ltd.

Division name

Research Institute

Zip code

Address

2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama

TEL

045-571-2504

Homepage URL

Email

h-inagaki-jj@morinaga.co.jp

Institute

MORINAGA & CO.,Ltd.

Institute

Department

Personal name

Organization

MORINAGA & CO.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京工科大学（東京都）

Date of disclosure of the study information

2018

Year

07

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Nine participants in the amazake group and 9 in the placebo group were analyzed 5 weeks after intervention. There was no significant difference in the mean of pore slacking ratio of both groups before the consumption, but the difference was significant decrease after consumption of amazake. The rate of change in mean of pore slacking ratio was significantly decreased at 5 weeks after consumption of amazake compared to placebo. There was no significant difference in the mean of color tone of spots of both groups before the consumption, but the difference was significant improve after consumption of amazake. The amount of change in mean of color tone of spots was significant improve at 5 weeks after consumption of amazake compared to placebo.

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

11

Month

04

Day

Date of IRB

Anticipated trial start date

2016

Year

12

Month

20

Day

Last follow-up date

Date of closure to data entry

2017

Year

10

Month

11

Day

Date trial data considered complete

2017

Year

10

Month

11

Day

Date analysis concluded

2017

Year

10

Month

11

Day

Other related information

Registered date

2017

Year

01

Month

13

Day

Last modified on

2017

Year

10

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029489