UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification of skin condition improvement effect by intake of fermented food of lactic acid bacterium N320 strain
Title of the study (Brief title)	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	Takashi Koikeda
Organization	Shiba Palace Clinic
Division name	Chair
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	Ko Masuda
Organization	SOUKEN Co., Ltd
Division name	Management Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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