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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033638
Receipt No. R000038356
Official scientific title of the study Evaluate changes in skin condition due to ingestion of health foods
Date of disclosure of the study information 2018/08/09
Last modified on 2018/08/06

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Basic information
Official scientific title of the study Evaluate changes in skin condition due to ingestion of health foods
Title of the study (Brief title) Evaluate changes in skin condition due to ingestion of health foods
Region
Japan

Condition
Condition Healthy adult woman
Classification by specialty
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Evaluate the influence on skin conditions due to ingestion of test articles
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of skin condition before starting taking the test article and 12 weeks after intake
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Taking the test sample for 12 weeks
Interventions/Control_2 No intervention
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
59 years-old >
Gender Female
Key inclusion criteria 1.Subjects aged 20 to 59
2.Subjects who feels a weakness of skin elasticity and skin elasticity
Key exclusion criteria 1.Subjects who have a history of food allergies
2.Subjects who are pregnant or lactating
3.Subjects taking medicines that can bring about effects on facial skin conditions
4.Subjects who have participated in other human examinations within the past 4 weeks
Target sample size 24

Research contact person
Name of lead principal investigator Masatomo Najima
Organization Japan clinical trial association
Division name N.A.
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Email info@yakujihou.org

Public contact
Name of contact person Takeshi Kaneko
Organization Japan Clinical Trial Association
Division name N.A.
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Homepage URL
Email info@yakujihou.org

Sponsor
Institute Japan clinical trial association
Institute
Department

Funding Source
Organization EC STUDIO Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 08 Month 09 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 19 Day
Anticipated trial start date
2018 Year 08 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 06 Day
Last modified on
2018 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038356

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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