UMIN-CTR Clinical Trial

Basic information
Public title	The study on the influence on skin by continuous intake of sub-aleurone layer residual rinse-free rice and dewed brown rice
Acronym	The study on the influence on skin by continuous intake of sub-aleurone layer residual rinse-free rice and dewed brown rice
Scientific Title	The study on the influence on skin by continuous intake of sub-aleurone layer residual rinse-free rice and dewed brown rice
Scientific Title:Acronym	The study on the influence on skin by continuous intake of sub-aleurone layer residual rinse-free rice and dewed 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 test is to conduct a human test on the change of skin quality after continuous intake of sub-aleurone layer residual wash-free rice and dewaxed brown rice remaining in the paste layer, and to evaluate it.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	A group that consumes 150g or more of sub-aleurone layer residual rinse -free rice once a day
Interventions/Control_2	Group for consumes 150g or more of dewaxed brown rice once a day
Interventions/Control_3	Free intake group
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	[1]Japanese males and females aged 18-59 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]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 whose BMI is over 30 kg/m2 [7]Individuals who are sensitive to test products or Individual with fear who causes severe allergy in a food and medical supplies [8]Individual who is pregnant or lactate [9]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 [10] Individuals diagnosed with photosensitivity [11]Individuals judged inappropriate for the study by the principal
Target sample size	100

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	104-0061
Address	5-10-13,Ginza,Chuo-ku,Tokyo
TEL	03-3572-7550
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
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	2019 Year 06 Month 11 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	103
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	2019 Year 05 Month 31 Day
Date of IRB	2019 Year 06 Month 08 Day
Anticipated trial start date	2019 Year 06 Month 11 Day
Last follow-up date	2019 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 06 Month 10 Day
Last modified on	2019 Year 11 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042162