UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect on blood pressure of a rice bran peptide containing foods.- Randomized placebo controlled study-
Title of the study (Brief title)	The effect on blood pressure of a rice bran peptide containing foods.
Region	Japan

Condition
Condition	Persons with high-normal blood pressure or mild hypertension
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the improvement of blood pressure of repeated ingestion for 12 weeks of a rice bran peptide containing foods.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	systolic blood pressure and diastolic blood pressure at 4,8 and 12 weeks after intake
Key secondary outcomes	count of adverse event average of adverse event count of adverse effect average of adverse effect

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	4
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	a rice bran peptide non-containing foods, 12 weeks
Interventions/Control_2	a rice bran peptide containing foods (500mg/day), 12 weeks
Interventions/Control_3	a rice bran peptide containing foods (1000mg/day), 12 weeks
Interventions/Control_4	a rice bran peptide containing foods (2000mg/day), 12 weeks
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 more than 130 mmHg and less than 159 mmHg systolic blood pressure or more than 85 mmHg less than 99 mmHg diastolic blood pressure 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 Subjects who have marked impairment of liver,kidney,heart,lung,endocrine,metabolism,nerve,or consciousness, or have DM. 2 Individual given surgery within 2 months before the final examination. 3 Medicine user for hyperglycaemia,lipidemia,or hypertension. 4 Individual intakes the food for specific use of health authorized the government and foods with function claims. 5 Individual experienced unpleasant feeling by drawing blood in the past. 6 Individual donated 200 ml or more of blood within a month prior to the study. 7 Individual changed weight 2 kg or more within 1month before the trial. 8 Night worker and shift worker. 9 Individual plans business trip for 10 consecutive days or more. 10 Individual can't intake test meal. 11 Individual had allergy against any constituents in the test meal. 12 Individual can not conform to control of alcohol(equivalent of 500 ml of beer per day). 13 Individual can not conform to record of"life diary"every day during the period of the test. 14 Individual can not conform to record of daily diet for 9 days(3 days x 3 times). 15 Individual cannot allow operator to consult his/her data of the past health check. 16 Individual have already participated other clinical trial and will participate. 17 Individual can not agree with preliminary explanation. 18 Pregnant women or breast-feeding women. 19 Individual who was judged ineligibles by clinician in this trial.
Target sample size	80

Research contact person
Name of lead principal investigator	Motonobu Matsumoto
Organization	Sunstar Inc.
Division name	General Manager R&D
Address	3-1, Asahimachi, Takatsuki, Osaka,Japan
TEL	072-682-5570
Email	motonobu.matsumoto@jp.sunstar.com

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

Sponsor
Institute	New Drug Research Center, 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)

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	2016 Year 09 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 25 Day
Anticipated trial start date	2016 Year 08 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2017 Year 01 Month 12 Day
Date analysis concluded

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

Management information
Registered date	2016 Year 09 Month 08 Day
Last modified on	2017 Year 11 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027608