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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043510
Receipt No. R000049667
Scientific Title The study on the influence on skin by continuous intake of sub-aleurone-remaining wash-free rice and dewaxed brown rice
Date of disclosure of the study information 2021/03/10
Last modified on 2021/05/25

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Basic information
Public title The study on the influence on skin by continuous intake of sub-aleurone-remaining wash-free rice and dewaxed brown rice
Acronym The study on the influence on skin by continuous intake of sub-aleurone-remaining wash-free rice and dewaxed brown rice
Scientific Title The study on the influence on skin by continuous intake of sub-aleurone-remaining wash-free rice and dewaxed brown rice
Scientific Title:Acronym The study on the influence on skin by continuous intake of sub-aleurone-remaining wash-free rice and dewaxed brown rice
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to conduct a cross-sectional study in a wide range of age groups and evaluate the effects of continuous daily intake of sub-aleurone-remaining wash-free rice,dewaxed brown rice and white rice on the skin.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measurement of skin function by Clreo-Pro
Key secondary outcomes Questionnaire survey

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
18 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria [1]Japanese males and females aged 18-89 years
[2]Individuals who are healthy and are not received treatment of disease
[3]Individuals whose written informed consent has been obtained
[4]Individuals who can come to the designated examination date and receive the examination
[5]Sub-aleurone-remaining wash-free rice group and dewaxed brown rice group are those who have eaten for more than one month from the date of inspection
[6]Individuals judged appropriate for the study by the principal
Key exclusion criteria [1]Individuals using medical products
[2]Individuals who are or are under treatment or have a history of Impaired Glucose Tolerance,mental disabilities,sleep disorder,hypertension,diabetes,fat metabolism or the other serious dysfunctions
[3]Individuals who used a drug to treat in the past 1 month (One-shot medicine of a headache, menstrual pain and a cold removes it.)
[4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease,or blood disease
[5]Individual who have digestive organ disease(disease of an appendix is removed)
[6]Individuals who are sensitive to test products or Individual with fear who causes severe allergy in a food and medical supplies
[7]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments of skincare in the past 3 month or will ingest those foods during the test period
[8] Individuals diagnosed with photosensitivity
[9]Individuals judged inappropriate for the study by the principal
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Seki
Organization TOYO RICE CORPORATION
Division name Planning and Public Relations Department
Zip code 104-0061
Address 5-10-13,Ginza,Chuo-ku,Tokyo
TEL 03-3572-7550
Email seki-hiroyuki@toyo-rice.jp

Public contact
Name of contact person
1st name Marin
Middle name
Last name Kawakami
Organization TOYO RICE CORPORATION
Division name Planning and Public Relations Department
Zip code 640-8341
Address 12,Kuroda,Wakayama-City,Wakayama
TEL 073-471-3011
Homepage URL
Email kawakami-marin@toyo-rice.jp

Sponsor
Institute TOYO RICE CORPORATION
Institute
Department

Funding Source
Organization TOYO RICE CORPORATION
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Anti-Aging Medical Research Center,Graduate School of Life and Medical Sciences,Doshisha University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Society of Glycative Stress Research
Address 5F-11,Musashino Bldg,2-13-10 Shinjuku,Shinjuku-ku,Tokyo
Tel 03-6709-8842
Email rinri-glycativestress@antiaging-bank.com

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
2021 Year 03 Month 10 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 Enrolling by invitation
Date of protocol fixation
2021 Year 02 Month 18 Day
Date of IRB
2021 Year 03 Month 03 Day
Anticipated trial start date
2021 Year 03 Month 10 Day
Last follow-up date
2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Compare and verify the skin quality of those who have eaten sub-aleurone-remaining wash-free rice,dewaxed brown rice and white rice for more than a month.

Management information
Registered date
2021 Year 03 Month 03 Day
Last modified on
2021 Year 05 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049667

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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