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Recruitment status Completed
Unique ID issued by UMIN UMIN000031284
Receipt No. 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

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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

Condition N/A(healthy adults)
Classification by specialty
Classification by malignancy Others
Genomic information NO

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

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).

[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).

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

No. of arms 2
Purpose of intervention Treatment
Type of intervention
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).

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

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

Institute TES Holdings Co., Ltd.

Funding Source
Organization HAYASHIBARA CO., LTD.
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
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

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2


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

URL related to results and publications
Number of participants that the trial has enrolled 40
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 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 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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name

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