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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023982
Receipt No. R000027608
Scientific Title The effect on blood pressure of a rice bran peptide containing foods.- Randomized placebo controlled study-
Date of disclosure of the study information 2016/09/08
Last modified on 2017/11/20

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Basic information
Public title The effect on blood pressure of a rice bran peptide containing foods.- Randomized placebo controlled study-
Acronym The effect on blood pressure of a rice bran peptide containing foods.
Scientific Title The effect on blood pressure of a rice bran peptide containing foods.- Randomized placebo controlled study-
Scientific Title:Acronym 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
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 072-682-5570
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 452-1, 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)

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
2016 Year 09 Month 08 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 07 Month 25 Day
Date of IRB
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

Other
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

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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