UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on improvement of skin quality with almond chocolate intake
Title of the study (Brief title)	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	Maiko Tajima
Organization	Beauty & Health Research_Inc
Division name	Medical Research Department
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	Ai Marume
Organization	Beauty & Health Research_Inc
Division name	Medical Research Department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 21 Day
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

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Publication of results	Unpublished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