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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025966
Receipt No. R000029763
Scientific Title Study on improvement of skin quality with almond chocolate intake
Date of disclosure of the study information 2017/02/02
Last modified on 2017/07/07

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Basic information
Public title Study on improvement of skin quality with almond chocolate intake
Acronym Study on improvement of skin quality with almond chocolate intake
Scientific Title Study on improvement of skin quality with almond chocolate intake
Scientific Title:Acronym Study on improvement of skin quality with almond chocolate intake
Region
Japan

Condition
Condition healthy volunteer
Classification by specialty
Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Study on skin quality improvement effect when almond chocolate is continuously ingested for 8 weeks
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) defecation, flights, flights quantity, bowel movement days
2) stratum corneum turnover
3) serum inflammatory markers (TARC) 4) by dermatologist skin drying condition rating
5) stratum corneum moisture volume 6) percutaneous skin moisture transpiration rate amount
7) skin image analysis (age spots, wrinkles, texture, quantitative evaluation of pores, UV spots, Porphyrin, Brown freckles (melanin), red (hemoglobin))
8) awareness survey (investigation of subjective symptoms of intestinal and skin)
Key secondary outcomes 1) skin enlarged image
2) Lipids in the stratum corneum (horny cell covalently bonded ceramide)
3) Blood spoilage product
4) Eye buttock ski score evaluation

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 Test food intake group (8 grains a day for 8weeks)
Interventions/Control_2 Test food non-intake group (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
25 years-old <=
Age-upper limit
49 years-old >=
Gender Female
Key inclusion criteria 1) Those who received a sufficient explanation of the purpose and contents of this exam, who have the capacity to consent, voluntarily volunteer with full understanding, and who agreed to participate in the document
2) Women who are 25 years old or older and under 50 years old who have a defecation frequency of 2 to 4 times per week for the most recent 2 weeks at the time of screening
3) Person who has conscious of drying of skin at screening
Key exclusion criteria 1) Currently, those who have some sort of chronic illness and are undergoing drug treatment
2) Persons who have severe hay fever symptoms
3) Persons who have significant abnormalities in the skin condition of the test site
4) Persons who are allergic to cocoa, almonds, milk, wheat, eggs, soybeans
5) Persons who regularly consume cacao products, nuts on a daily basis
6) Those who ingested or ingested medicines, quasi-drugs, supplements, health foods, foods for specified health use, functional display foods that are likely to affect this test in the course of three months before screening , Those who are scheduled to take or intake during the exam
7) Persons conducting special facial care (Facial Equipment, Aesthetic, Peeling, Laser Therapy etc.)
8) Participants in other clinical and monitoring studies during the first month before screening
9) Persons who are pregnant, plan for pregnancy during the examination period, those whohave hope
10) Breast feeding
11) Others who judged that the investigatoror the test sharing doctor is inappropriateas the subject
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Maiko Tajima
Organization Beauty & Health Research_Inc
Division name Medical Research Department
Zip code
Address Sankyo Nisisinnjuku Buiding 4F 4-2-18 Nisisinnjuku Shinjuku-ku Tokyo, 160-0023 Japan
TEL 03-5354-7388
Email info@b-hr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ai Marume
Organization Beauty & Health Research_Inc
Division name Medical Research Department
Zip code
Address Sankyo Nisisinnjuku Buiding 4F 4-2-18 Nisisinnjuku Shinjuku-ku Tokyo, 160-0023 Japan
TEL 03-5354-7388
Homepage URL
Email marume@b-hr.jp

Sponsor
Institute Beauty & Health Research Inc
Institute
Department

Funding Source
Organization Meiji 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
Address
Tel
Email

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 株式会社ビューティアンドヘルスリサーチ(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 02 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
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
2016 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 02 Day
Last modified on
2017 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029763

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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