UMIN-CTR Clinical Trial

Basic information
Public title	Safety confirmation study by overdose of a rice bran peptide containing foods. - Randomized placebo controlled study-
Acronym	Safety confirmation study by overdose of a rice bran peptide containing foods.
Scientific Title	Safety confirmation study by overdose of a rice bran peptide containing foods. - Randomized placebo controlled study-
Scientific Title:Acronym	Safety confirmation study by overdose of a rice bran peptide containing foods.
Region	Japan

Condition
Condition	Persons with normal(including high-normal blood pressure) or mild hype
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the safety of overdose for 4 weeks of a rice bran peptide containing foods.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	-
Key secondary outcomes	<Safety> Side effect incidence, Adverse event incidence, clinical examination items, physical measurement items(excluding height) and physiological examination items

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Rice bran peptide non-formulated food, 4 weeks
Interventions/Control_2	Rice bran peptide-containing food, 4 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	35 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1 Males and females equal to or more than 35 years and less than 65 years of age 2 Subjects who contain normal value <= systolic blood pressure <= 159 mmHg or normal value <= diastolic blood pressure <= 99 mmHg 3 Possible study volunteer to visit 4 Subjects who recognize the object and contents of the study and submit the written informed consent
Key exclusion criteria	1 Pregnant women or breast-feeding women. 2 Individual donated 400 ml of blood within 12weeks or component blood donation 200 ml of blood within 4weeks prior to the study. 3 Individual have already participated other clinical trial or within 4 weeks of examination end. 4 Subjects who have marked impairment of heart, liver, kidney, thyroid, and other diseases. 5 Subjects who have a history of cardiovascular disease. 6 Subjects who develop diabetes (Recommended by Japan Diabetes Society). 7 Subjects who have food allergy against brown rice, rice bran, and rice. 8 Individual experienced unpleasant feeling by drawing blood in the past. 9 Heavy drinkers 10 Heavy Smokers(More than daily an average of 21 of them) 11 Subjects whose eating habits are extremely irregular. 12 Subjects who take medications that may affect this exam. 13 Subjects who regularly using foods such as specified health foods and functional display foods that may affect this inspection. 14 Secondary hypertension 15 Subjects who have a history of large surgery (gastrectomy, gastrointestinal suture, intestinal resection) on the gastrointestinal except who resect the cecum. 16 Individual who was judged ineligibles by clinician in this trial.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Motonobu Matsumoto
Organization	Sunstar Inc.
Division name	General Manager R&D
Zip code
Address	3-1, Asahimachi, Takatsuki, Osaka,Japan
TEL	072-693-3061
Email	motonobu.matsumoto@jp.sunstar.com

Public contact
Name of contact person	1st name Middle name Last name Yoshitaka Hatakeyama
Organization	New Drug Research Center, Inc.
Division name	Clinical Research Dept.
Zip code
Address	452-1Toiso,Eniwa-shi,Hokkaido, Japan
TEL	0123-34-0412
Homepage URL
Email	y-hatakeyama@ndrcenter.co.jp

Sponsor
Institute	Sunstar Inc.
Institute
Department

Funding Source
Organization	Sunstar Inc.
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

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 07 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	2018 Year 08 Month 09 Day
Date of IRB
Anticipated trial start date	2018 Year 09 Month 21 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	2018 Year 09 Month 04 Day
Last modified on	2019 Year 03 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038289

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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