UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025249 |
|---|---|
| Receipt number | R000029039 |
| Scientific Title | A study for the effect of the intake of an aojiru beverage on microflora |
| Date of disclosure of the study information | 2016/12/13 |
| Last modified on | 2023/12/07 10:27:21 |
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Basic information
Public title
A study for the effect of the intake of an aojiru beverage on microflora
Acronym
A study for the effect of the intake of an aojiru beverage on microflora
Scientific Title
A study for the effect of the intake of an aojiru beverage on microflora
Scientific Title:Acronym
A study for the effect of the intake of an aojiru beverage on microflora
Region
| Japan |
Condition
Condition
rough skin, dry skin
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The object of this study is to evaluate the mechanism of improvement of skin conditions by aojiru beverage intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Measurement of skin conditions (measurement time: 0,4,8 weeks after ingestion of the test bevarage)
Measurement of microflora (measurement time: 0,8 weeks after ingestion of the test bevarage)
Key secondary outcomes
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 an aojiru bevarage twice a day for 8weeks
Interventions/Control_2
Ingestion of a placebo bevarage twice a day for 8weeks
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
| Not applicable |
Gender
Female
Key inclusion criteria
1.Healthy female 20 years of age or more
2.Subjects who have rough skin by drying or other skin problems
3.Subjects who can make self-judgement and are voluntarily giving written informed consents
4.Subjects who can obey the directions of the investigators
Key exclusion criteria
1.Subjects who take antibiotics within the last two months prior to the current study or who take intestinal drugs daily
2.Subjects who are under treatment by a dermatologist for dry skin, inflammation or other skin diseases. Or difficulty with measuring points by scars or other skin problems
3.Subjects who are serious constipated or contract serious diseases of anus or intestines
4.Subjects who contract diseases which may affect the current study
5.Subjects who are menstrual irregularity (except for menopause)
6.Subjects who take other aojiru, foods which influence intestinal functions, supplements, other specified foods daily, and they are not able to stop during the current study period
7.Subjects who have declared allergic reaction to test foods
8.Subjects who are under treatment for or have a history of drug addiction or alcoholism
9.Subjects who are pregnant or are planning to become pregnant after informed consent for the current study
10.Subjects who are planning to participate and/or are participating in other clinical studies
11.Subjects who are judged as unsuitable for the current study by the investigator for other reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yamaguchi |
| Middle name | |
| Last name | Kazuya |
Organization
TOYO SHINYAKU Co., Ltd.
Division name
Research Promotion Office
Zip code
841-0005
Address
7-28 Yayoigaoka,Tosu-Shi,Saga
TEL
0942-81-3555
yamaguchik@toyoshinyaku.co.jp
Public contact
Name of contact person
| 1st name | Kusaba |
| Middle name | |
| Last name | Nobutaka |
Organization
TOYO SHINYAKU Co., Ltd.
Division name
Research Promotion Office
Zip code
841-0005
Address
7-28 Yayoigaoka,Tosu-Shi,Saga
TEL
0942-81-3555
Homepage URL
gakujutsu@toyoshinyaku.co.jp
Sponsor or person
Institute
TOYO SHINYAKU Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
TOYO SHINYAKU 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
Ethics Committees of Nihonbashi Egawa Clinic
Address
1-1-3 Yaesu Chuo-ku, Tokyo, Japan
Tel
03-5733-0441
jim@medipharma.co.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
| 2016 | Year | 12 | Month | 13 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000029039
Publication of results
Published
Result
URL related to results and publications
http://www.jsbba.or.jp/MeetingofJSBBA/2018/MeetingofJSBBA2018.pdf
Number of participants that the trial has enrolled
30
Results
Continual YBLP(Young barley leaf powder) ingestion tended to increase a beneficial bacterium, and decrease unhealthy bacteria in gut microbiome.
Results date posted
| 2019 | Year | 11 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy adult females
Participant flow
28 healthy adult females.
Adverse events
No side effects were noted.
Outcome measures
Measurement of skin conditions (measurement time: 0,4,8 weeks after ingestion of the test bevarage)
Measurement of microflora (measurement time: 0,8 weeks after ingestion of the test bevarage)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 26 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 10 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 13 | Day |
Last modified on
| 2023 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029039
