UMIN-CTR Clinical Trial

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

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Shiba Palace Clinic

Institute

Department

Personal name

Organization

Nissin Foods Holdings Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

12

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

12

Month

11

Day

Last modified on

2017

Year

12

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034637