UMIN-CTR Clinical Trial

Public title

Effects of a Test Food for Skin Quality, Defecation Improvement and Intestinal Flora

Acronym

Effects of a Test Food for Skin Quality, Defecation Improvement and Intestinal Flora

Scientific Title

Effects of a Test Food for Skin Quality, Defecation Improvement and Intestinal Flora

Scientific Title:Acronym

Effects of a Test Food for Skin Quality, Defecation Improvement and Intestinal Flora

Region

Japan

Condition

N/A(healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to evaluate effects of a test food for skin quality, defecation improvement and intestinal flora.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[1]Skin quality evaluation (Transepidermal water loss, skin moisture content, skin viscoelasticity, image analysis by VISIA, observation for skin condition by dermatologists)⁽¹⁾ and indexes for evaluating defecation and intestinal flora (analysis of intestinal flora, organic acid analysis, putrefaction products, ammonia analysis, the Japanese Version of the Constipation Assessment Scale [middle term], Bristol stool scale, bowel diary) <sup>(2), (3),(4)

(1)</sup>Transepidermal water loss, skin moisture content, skin viscoelasticity, image analysis by VISIA, observation for skin condition by dermatologists (Week 0, Week 4)
⁽²⁾analysis of intestinal flora, organic acid analysis, putrefaction products, ammonia analysis (Week 0, Week 4)
⁽³⁾ the Japanese Version of the Constipation Assessment Scale [middle term], Bristol stool scale (Week 0, home survey, Week 4)
⁽⁴⁾Bowel diary (from the first day of ingestion of a test material to the last day of the test)

Key secondary outcomes

*Secondary outcome
[1]Questionnaire of physical feeling (Week 0, home survey, Week 4)

*Safety
[1]Doctor's questions (Week 0, Week 4)

*Other index
[1]Subject's diary(From the first day of ingestion of a test material to the last day of the test)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Oral ingestion of a test food (2 packs once a day for 4 weeks)

Interventions/Control_2

Interventions/Control_3

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

60

years-old

>

Gender

Female

Key inclusion criteria

[1]Healthy Japanese females aged 30-59 years.
[2]Individuals who are aware of skin dryness.
[3]Individuals with a tendency for constipation (at 3-4 times of defecation per week).
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can have an examination on a designated check day.
[6]Individuals judged appropriate for the study by the principal.

Key exclusion criteria

[1]Individuals whose dietary pattern is irregular.
[2]Individuals who intake a food containing lactic acid bacterium over 4 days in a week.
[3]Individuals using medical products.
[4]Individuals who intake laxatives, antiflatulent etc. aiming to improve bowel movements.
[5]Individuals who take medicine in the past 1 month to remedy disease.
[6]Individuals who take antibiotics in the past 1 month.
[7]Individuals with skin disease, such as atopic dermatitis.
[8]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease, or blood disease.
[9]Individual who have or had digestive organ disease.
[10]Individuals whose BMI is over 30.
[11]Individuals who are sensitive to test product or other foods, and medical products.
[12]Individuals who are or are possibly pregnant, or are lactating.
[13]Individuals who are alcohol dependent or have other mental disabilities.
[14]Individuals who are smoker.
[15]Individuals with possible changes of life style, such as working a night shift, during the test period.
[16]Individuals who will develop seasonal allergy symptoms like hay fever.
[17]Individuals who will get sunburned during the test period.
[18]Individuals who had a habit to ingest health-promoting foods, or supplements in the past 3 months or will ingest those foods during the test period.
[19]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[20]Individuals who use cosmetics having a strong moisturizing effect or improving effect for wrinkle.
[21]Individuals who have received a cosmetic medicine.
[22]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[23]Individuals who cannot collect fecal samples in their own house and submit them to the designated organization.
[24]Individuals who are or whose family is engaged in healthy or functional foods.
[25]Individuals judged inappropriate for the study by the principal.

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Shuji Nakata

Organization

Medical Corporation Bokushinkai CLINTEXE Clinic

Division name

Head

Zip code

Address

4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN

TEL

03-5405-1059

Email

info@tes-h.co.jp

Name of contact person

1st name
Middle name
Last name	Ryoma Shimizu

Organization

TES Holdings Co., Ltd

Division name

Administrative Department of Clinical Trials

Zip code

Address

6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN

TEL

03-6801-8480

Homepage URL

Email

r.shimizu@tes-h.co.jp

Institute

TES Holdings Co., Ltd

Institute

Department

Personal name

Organization

Information is disclosed with permission by the ethical committee.

Organization

Division

Category of Funding Organization

Other

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

09

Month

28

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

2017

Year

09

Month

08

Day

Date of IRB

Anticipated trial start date

2017

Year

09

Month

28

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

09

Month

28

Day

Last modified on

2017

Year

12

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033482