UMIN-CTR Clinical Trial

Public title

Effects of a Test Food for Skin Conditions

Acronym

Effects of a Test Food for Skin Conditions

Scientific Title

Effects of a Test Food for Skin Conditions

Scientific Title:Acronym

Effects of a Test Food for Skin Conditions

Region

Japan

Condition

N/A(healthy adaults)

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to examine effects of a test food for skin conditions.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[1]Indexes for skin conditions (skin moisture content, transepidermal water loss, skin viscoelasticity, visual evaluation: Week 0, Week 4, Week 8)

Key secondary outcomes

[1]Doctor's questions (Week 0, Week 4, Week 8)
[2]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

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

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Oral ingestion of the test food (8 weeks)

Interventions/Control_2

Oral ingestion of the placebo food (8 weeks)

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

Male and Female

Key inclusion criteria

[1]Japanese females aged 30-59 years.
[2]Individuals who are healthy and are not suffered from a chronic malady including skin disease.
[3]Individuals who are anxious about skin dryness.
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can visit an inspection facility and be inspected in designated days.
[6]Individuals judged appropriate for the study by the principal.

Key exclusion criteria

[1]Individuals using medical products.
[2]Individuals with skin disease, such as atopic dermatitis.
[3]Individuals with strange skin conditions at measurement points.
[4]Individuals who used or applied a drug for treatment of disease in the past 1 month.
[5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
[6]Individuals who contract or have a history of serious gastrointestinal disease.
[7]Individuals with serious anemia.
[8]Individuals who are sensitive to test product (especially gelatin, leg meat, pork) or other foods, and medical products.
[9]Females who are or are possibly pregnant, or are lactating.
[10]Males who shave with a razor.
[11]Individuals who have an addiction to alcohol or a mental illness.
[12]Individuals who are a smoker.
[13]Individuals whose life style will change during the test period.
[14]Individuals with probable seasonal allergy, such as pollinosis, during the test period.
[15]Individuals who will get sunburned during the test period.
[16]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period.
[17]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period.
[18]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[19]Individuals who conducted hormone replacement therapy in the past 3 months or have a history of conducting hormone replacement therapy.
[20]Individuals who have received a cosmetic medicine in the past 6 months.
[21]Individuals who were hospitalized and received treatment in the past 6 months.
[22]Individuals who participated in other clinical studies in the past three months.
[23]Individuals judged inappropriate for the study by the principal.

Target sample size

36

Name of lead principal investigator

1st name
Middle name
Last name	Sadao Mori

Organization

MORINAGA&CO., LTD.

Division name

Internal Department

Zip code

Address

2-1-1 Shimosueyoshi Tsurumi-ku Yokohama-Shi Kanagawa 230-0012, JAPAN

TEL

070-3864-8266

Email

s-mori-ab@morinaga.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

Morinaga & 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

09

Month

11

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

08

Month

17

Day

Date of IRB

Anticipated trial start date

2017

Year

09

Month

08

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

11

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=R000033162