UMIN-CTR Clinical Trial

Public title

A confirmation study for the improvement effect of skin quality by the test food consumption

Acronym

A confirmation study for the improvement effect of skin quality by the test food consumption

Scientific Title

A confirmation study for the improvement effect of skin quality by the test food consumption

Scientific Title:Acronym

A confirmation study for the improvement effect of skin quality by the test food consumption

Region

Japan

Condition

Not applicable

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

To confirm the improvement effect of skin quality by consumption of the test food.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

*Moisture content of the horny layer
*Viscoelasticity of the skin
*Amount of water transpiration from the surface of the skin
*VISIA's indicators(spots, wrinkles, texture, pores, UV spots, brown spots, red areas, porphyrins)

Key secondary outcomes

*Oil content of the skin
*Defecation frequency
*Days of defecation
*Fecal properties
*Feelings in defecation
*Microbiota of gut
*Short chain fatty acids of feces
*Fecal spoilage products
*Moisture of feces
*pH of feces
*Ammonia of feces
* QOL questionnaire
*The Japanese Version of the Constipation Assessment Scale MT version (CAS-MT)
*Simplified Menopausal Index (SMI)
*Body weight, Body fat percentage, BMI
*Blood test
*Urine test
* Incidence of adverse events and of side effects

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

Prevention

Type of intervention

Food

Interventions/Control_1

Consume testfood-1, one package a day for 10 weeks. Conduct health check, QOL questionnaire and stool analysis at 0, 4 and 8 weeks, skin tests at 4 and 8 weeks, blood tests at 8 weeks after start of the testfood-1 consumption.

Interventions/Control_2

Consume testfood-2, one package a day for 10 weeks. Conduct health check, QOL questionnaire and stool analysis at 0, 4 and 8 weeks, skin tests at 4 and 8 weeks, blood tests at 8 weeks after start of the testfood-2 consumption.

Interventions/Control_3

Consuming control food, one package a day for 10 weeks. Conduct health check, QOL questionnaire and stool analysis at 0, 4 and 8 weeks, skin tests at 4 and 8 weeks, blood tests at 8 weeks after start of control food consumption.

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

30

years-old

<=

Age-upper limit

49

years-old

>=

Gender

Female

Key inclusion criteria

(1) Females aged 30 to 49 years old.
(2)Subjects who are before menopause and have stable menstrual period within 28 days to 35 days.
(3) Subjects who are aware to bad condition of their skin.
(4) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.

Key exclusion criteria

Subjects who
(1)consume yogurt over 3 days a week.
(2)consume lactic acid bacteria beverages and/or bifidobacterium beverages over 3 days a week.
(3)consume health food which have intestinal action.
(4)consume supplements include lactic bacteria, bifidobacterium and/or yeast over 3 days a week.
(5)consume vitamin supplements over 3 days a week.
(6)regularly use gastrointestinal agonist and/or female hormone.
(7)repeat constipation and diarrhea.
(8)defecate under 2 times in a week.
(9)defecate over 10 times in a week.
(10)have taken antibiotics within a month
(11)are being treated uterine and/or that medical historie.
(12)are pregnant or are lactating.
(13)have allergy to medicine and/or food.
(14)are atopic dermatitis, contact dermatitis and/or skin hypersensitivity.
(15)Subjects who have birthmark, scar and/or acne on the part of measurement.
(16)have severe past and/or current medical history in heart, liver, kidney and/or digestive organs.
(17)are heavy drinkers of alcohol.
(18)have excess irregular life rhythm such as shift work or midnight work.
(19)are currently being treated or who plan to be treated for pollen allergy.
(20)have rough skin because of pollen allergy.
(21)have excess suntan and/or who stay outside long time.
(22)are receiving special care of face and/or arm in the service.
(23)plan to go traveling abroad and/or to go swimming in the sea during this test period.
(24)are participating, have participated within 4 weeks and/or who plan to participate after informed consent of this test, in clinical test of other medicine or health food.
(25)donated over 200mL blood and/or blood components within a month.
(26)donated over 400mL blood within the last 4 months.
(27)will be collected over 800mL blood and/or blood components when the sampling amounts within the last 12 months are adding to the planned sampling amounts of this study.
(28)Others they have been determined ineligible by principal investigator or sub-investigator.

Target sample size

75

Name of lead principal investigator

1st name	Suguru
Middle name
Last name	Fujiwara

Organization

CPCC Company Limited

Division name

Clinical Research Planning Department

Zip code

101-0047

Address

4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

TEL

03-5297-3112

Email

cpcc-contact@cpcc.co.jp

Name of contact person

1st name	Masanori
Middle name
Last name	Numa

Organization

CPCC Company Limited

Division name

Planning & Sales Department

Zip code

101-0047

Address

4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

TEL

03-5297-3112

Homepage URL

Email

cpcc-contact@cpcc.co.jp

Institute

CPCC Company Limited

Institute

Department

Personal name

Organization

Asahi Group Holdings, Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan

Tel

03-5297-5548

Email

IRB@cpcc.co.jp

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

2019

Year

09

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

75

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

2018

Year

07

Month

26

Day

Date of IRB

2018

Year

07

Month

19

Day

Anticipated trial start date

2018

Year

09

Month

03

Day

Last follow-up date

2018

Year

12

Month

19

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

08

Month

29

Day

Last modified on

2020

Year

10

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038715