UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000031284
Receipt number R000035442
Scientific Title Effect of a Test Food for Skin
Date of disclosure of the study information 2018/02/15
Last modified on 2019/09/05 14:09:49

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Basic information

Public title

Effect of a Test Food for Skin

Acronym

Effect of a Test Food for Skin

Scientific Title

Effect of a Test Food for Skin

Scientific Title:Acronym

Effect of a Test Food for Skin

Region

Japan


Condition

Condition

N/A(healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study examines effects of the test food on male's and female's skin condition.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

[1]Skin quality evaluation (skin moisture content, Transepidermal water loss, observation for skin condition by dermatologists) (before and afte ingestion).

Key secondary outcomes

*Secondary outcomes
[1]Blood phenol level (before and afte ingestion).
[2]Blood p-cresol level (before and afte ingestion).
[3]Subject's diary (From the first day of ingestion of a test material to the last day of the test).
[4]Questionnaire of physical feeling (before and afte ingestion).

*Safety
[1]Hematologic test (before and afte ingestion).
[2]Blood biochemical test (before and afte ingestion).
[3]Urine analysis (before and afte ingestion).
[4]Doctor's questions (before and afte ingestion).


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Oral ingestion of the test food (1 pack once a day for 8 weeks).

Interventions/Control_2

Oral ingestion of the placebo food (1 pack once a day for 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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

60 years-old >

Gender

Male and Female

Key inclusion criteria

[1]Healthy Japanese males and females aged 20-59 years.
[2]Individuals who are healthy and have no chronic physical disease including skin disease.
[3]Individuals who are aware of skin dryness.
[4]Individuals with a tendency for constipation (at 4 times or less of defecation per week).
[5]Individuals whose written informed consent has been obtained.
[6]Individuals who can have an examination on a designated check day.
[7]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 or other foods, and medical products.
[9]Females who aware of rough skin before and after menstruation.
[10]Individuals who are or are possibly pregnant, or are lactating.
[11]Individuals who have an addiction to alcohol or a mental illness.
[12]Individuals who are a smoker.
[13]Individuals with possible changes of life style, such as working a night shift, during the test period.
[14]Individuals who will develop seasonal allergy symptoms like hay fever.
[15]Individuals who are excessively negligent of skin care.
[16]Individuals who cannot avoid daylight exposure during the test period (including winter sports like ski and snowboard).
[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 had been conducted an operation on the test spot.
[20]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[21]Individuals who participated in other clinical studies in the past 3 months.
[22]Individuals who are or whose family is engaged in healthy or functional foods, or cosmetics.
[23]Individuals judged inappropriate for the study by the principal.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Shuji
Middle name
Last name Nakada

Organization

Medical Corporation Bokushinkai CLINTEXE Clinic

Division name

Head

Zip code

105-6204

Address

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

TEL

+81-3-5405-1059

Email

info@tes-h.co.jp


Public contact

Name of contact person

1st name Ryoma
Middle name
Last name Shimizu

Organization

TES Holdings Co., Ltd.

Division name

Administrative Department of Clinical Trials

Zip code

113-0033

Address

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

TEL

+81-3-6801-8480

Homepage URL


Email

r.shimizu@tes-h.co.jp


Sponsor or person

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

HAYASHIBARA CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Ethics Committee of the Oriental Ueno Detection Center, General Incorporated Association Oriental Occupational Health Association Tokyo Branch

Address

1-20-11 Ueno Taito-ku Tokyo 110-0005, JAPAN

Tel

+81-3-5816-0711

Email

i.takahashi@tes-h.co.jp


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

2018 Year 02 Month 15 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

40

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



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 01 Month 22 Day

Date of IRB

2018 Year 01 Month 23 Day

Anticipated trial start date

2018 Year 02 Month 17 Day

Last follow-up date

2018 Year 04 Month 17 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 02 Month 13 Day

Last modified on

2019 Year 09 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035442


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name