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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030349
Receipt No. R000034637
Scientific Title Verification of skin condition improvement effect by intake of fermented food of lactic acid bacterium N320 strain
Date of disclosure of the study information 2017/12/12
Last modified on 2017/12/13

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Basic information
Public title Verification of skin condition improvement effect by intake of fermented food of lactic acid bacterium N320 strain
Acronym Verification of skin condition improvement
Scientific Title Verification of skin condition improvement effect by intake of fermented food of lactic acid bacterium N320 strain
Scientific Title:Acronym Verification of skin condition improvement
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to verify the effect of skin condition improvement by ingesting fermented foods of lactic acid bacteria N320 strain, placebo-controlled double-blind study was conducted to evaluate stain image analysis (digital microscope, reflection), skin moisture transpiration measurement, skin moisture content measurement, skin elasticity measurement, texture image shooting (digital microscope, reflection), doctor's findings and evaluations, doctor's findings by a dermatologist, numerical analysis of stain image (digital microscope, no reflection), skin tone and color scale judgment (stains), stain grade judgment (Trained Expert), questionnaire survey, health diary.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Skin moisture transpiration measurement
Key secondary outcomes Stain image analysis (digital microscope, reflection)
Skin moisture transpiration measurement
Skin moisture content measurement
Skin elasticity measurement
Texture image shooting (digital microscope, reflection)
Doctor's findings and evaluations
Doctor's findings by a dermatologist
Numerical analysis of stain image (digital microscope, no reflection)
Skin tone and color scale judgment (stains)
Stain grade judgment (Trained Expert)
Questionnaire survey
Health diary

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 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Test food1
After breakfast
1 bottle once
Drink 100mL within 30 minutes after breakfast.
If you forget to drink after breakfast or if it is difficult to ingest the whole amount after breakfast, take it during the day. Do not carry over if you can not take it during the day.
Interventions/Control_2 Test food2
After breakfast
1 bottle once
Drink 100mL within 30 minutes after breakfast.
If you forget to drink after breakfast or if it is difficult to ingest the whole amount after breakfast, take it during the day. Do not carry over if you can not take it during the day.
Interventions/Control_3 Pracebo food
After breakfast
1 bottle once
Drink 100mL within 30 minutes after breakfast.
If you forget to drink after breakfast or if it is difficult to ingest the whole amount after breakfast, take it during the day. Do not carry over if you can not take it during the day.
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 Japanese males and females aged 35 to 59 years old at the time of acquiring consent on the first observation day (including screening)

Persons who are aware of dry skin

Persons who feel sagging skin

Persons who are aware of rough skin

Persons who are aware of rough skin due to drying, etc. on either the right cheek, right foot back, upper back, right neck, right shin, or who have itching symptoms (it is desirable when there is desquamation), or who have white powder blowing after bathing, every year from October to March

Persons who can abstain from the day before the observation date until the end of the measurement on the observation day

Persons who received a sufficient explanation of the purpose of this exam, have the capacity to consent, voluntarily volunteer for participation after understanding well, and who agreed in writing to participate in this study

Persons with stains on their face
Key exclusion criteria Persons who routinely consume health foods (such as supplements that promote skin beauty effects) that are likely to affect the test results

Persons who may show skin allergies symptoms and persons with skin hypersensitivity

Persons who are likely to have allergic symptoms depending on the test article component

Persons with cutaneous symptoms such as scratches, ruffles, warts, burns, art make, etc. that affect wrinkle evaluation around the outer corners of the eyes

Persons who currently go to dermatology department

During pregnancy or possibly pregnant, and those who are breastfeeding

Participating in other clinical trials

Persons taking or applying medicines (medicines with skin beautification effect such as moisture retention formulation) that are likely to affect the test results

Persons who use Mesaic eye tapes or eyelash extensions

Persons who are judged inappropriate to participate the study by the supervising doctor (When recognizing the fact that it is determined to be ineligible during the course of the test, it is excluded from the analysis subject. Note that inspection items that are not screening criteria are not an exclusion criterion from screening.)

Persons with significant abnormalities in the skin condition of the test site (upper back, right neck, right upper, right lower back and right cheek)

Persons who used cosmetics etc. with moisturizing effect at the site to be examined within 1 month before commencement of test

Persons taking or planning to take medicine with hay fever

Persons with chronic skin symptoms such as atopic dermatitis

Persons who ingested ceramide-containing supplements within 1 month before commencement of test

Persons who used ceramide and retinol compound cosmetics etc. within 1 month before commencement of test
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Koikeda
Organization Shiba Palace Clinic
Division name Chair
Zip code
Address 6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL 03-5408-1590
Email jimukyoku@mail.souken-r.com

Public contact
Name of contact person
1st name
Middle name
Last name Ko Masuda
Organization SOUKEN Co., Ltd
Division name Management Division
Zip code
Address 3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL 03-5408-1555
Homepage URL
Email k_masuda@mail.souken-r.com

Sponsor
Institute Shiba Palace Clinic
Institute
Department

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
Address
Tel
Email

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
2017 Year 12 Month 12 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 Completed
Date of protocol fixation
2016 Year 12 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 11 Day
Last modified on
2017 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034637

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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