UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035719 |
|---|---|
| Receipt number | R000040307 |
| Scientific Title | Verification of the effect of skin function improvement by intake of lactic acid bacteria. |
| Date of disclosure of the study information | 2020/01/30 |
| Last modified on | 2020/01/31 14:32:45 |
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Basic information
Public title
Verification of the effect of skin function improvement by intake of lactic acid bacteria.
Acronym
Verification of the effect of skin function improvement.
Scientific Title
Verification of the effect of skin function improvement by intake of lactic acid bacteria.
Scientific Title:Acronym
Verification of the effect of skin function improvement.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the effect of skin function improvement by intake of lactic acid bacteria.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in skin function before ingestion and after ingestion period
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Test food: ingestion of food containing lactic acid bacteria
1 cupsule/day, 8 weeks
Interventions/Control_2
Pracebo food: ingestion of food not containing lactic acid bacteria
1 cupsule/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
| 35 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Japanese men and women aged 35 to 59 years old at the time of acquiring consent
2) Persons who care about dry skin
3) Persons who feel sagging skin
4) Persons who are aware of rough skin
5) Persons who are aware of rough skin due to drying, etc. on either the right cheek, the right neck, the upper back, the right shank, the right foot back, or the left cheek, or who have itching symptoms (it is desirable when there is desquamation), or who have flaky skin after bathing, every year from October to March
6) Persons who can stop drinking alcohols from the day before the observation date until the end of the measurement on the observation day
7) Persons who received a sufficient explanation of the purpose of this exam, have the capacity to consent, volunteer for participation after understanding well, and who agreed in writing to participate in this study
8) Persons with stains on their right cheek
Key exclusion criteria
1) Persons who are judged inappropriate by the examining supervisor or doctor in charge of examination
2) Persons with chronic skin symptoms such as atopic dermatitis
3) Persons who used cosmetics containing hyaluronic acid, collagen, ceramide, vitamins etc. within 1 month before start of use
4) Persons who ingested supplements containing hyaluronic acid, collagen, ceramide, vitamins etc. within 1 month before start of use
5) Persons taking or planning to take medicine with hay fever
6) Persons who currently go to dermatology department
7) Persons participating in a test taking other foods or medicines, or applying cosmetics and medicines etc, or participated in similar exams in less than 3 months
8) Persons participating in other clinical trials
9) During pregnancy or planned, or those who are breastfeeding
10) Persons who may have an allergy such as having a history of hypersensitivity to the test article
11) Persons who are likely to have allergic symptoms depending on the test article components
12) Persons with significant abnormalities in the skin condition of the test site (cheek, upper back, neck, elbow, paw)
13) Persons who have chronic illness and regularly use medication
14) Persons who have athema
15) Persons with soy allergy
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Koikeda |
Organization
Shiba Palace Clinic
Division name
Chair
Zip code
1050013
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL
03-5408-1590
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | Ko |
| Middle name | |
| Last name | MASUDA |
Organization
SOUKEN Co., Ltd
Division name
Management Division
Zip code
1050013
Address
3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL
03-5408-1555
Homepage URL
k_masuda@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
Funding Source
Organization
NISSIN FOODS HOLDINGS 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
Shiba Palace Clinic Ethics Review Committee
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1590
jimukyoku@mail.souken-r.com
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
| 2020 | Year | 01 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 12 | 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 | 01 | Month | 30 | Day |
Last modified on
| 2020 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040307
