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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025663
Receipt No. R000029489
Official scientific title of the study Effect of Freeze-dried Amazake on the Defecation and the Condition of Skin in Healthy Adult Females.
Date of disclosure of the study information 2018/07/12
Last modified on 2017/10/11

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Basic information
Official scientific title of the study Effect of Freeze-dried Amazake on the Defecation and the Condition of Skin in Healthy Adult Females.
Title of the study (Brief title) Effect of Amazake on the Defecation and the Condition of Skin.
Region
Japan

Condition
Condition Verification of skin condition and bowel improvement effect of Amazake.
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes Skin condition 5weeks after intervention.
Key secondary outcomes Stool frequency, Consistency of stool, Volume of stool

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator Maeda, Kazuhisa
Organization Tokyo University of Technology
Division name School of Bioscience and Biotechnology
Address 1404-1 Katakuramachi, Hachioji
TEL 042-637-2442
Email kmaeda@stf.teu.ac.jp

Public contact
Name of contact person Inagaki, Hiroyuki
Organization MORINAGA & CO.,Ltd.
Division name Research Institute
Address 2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL 045-571-2504
Homepage URL
Email h-inagaki-jj@morinaga.co.jp

Sponsor
Institute MORINAGA & CO.,Ltd.
Institute
Department

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)

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 東京工科大学(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 12 Day

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 11 Month 04 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
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.
Other related information

Management information
Registered date
2017 Year 01 Month 13 Day
Last modified on
2017 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029489

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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