UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025966 |
|---|---|
| Receipt number | 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 17:06:30 |
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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
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
marume@b-hr.jp
Sponsor or person
Institute
Beauty & Health Research Inc
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029763
