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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028762
Receipt No. R000032448
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 2017/09/14
Last modified on 2018/09/04

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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.- Randomized placebo controlled study-
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.- Randomized placebo controlled study-
Region
Japan

Condition
Condition Persons with high-normal blood pressure or mild hype
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 <Efficacy>
systolic blood pressure,diastolic blood pressure
Key secondary outcomes <Safety>
Side effect incidence, Adverse event incidence, clinical examination items, and physiological examination items

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
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, 12 weeks
Interventions/Control_2 Rice bran peptide-containing food, 12 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
45 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1.Males and females equal to or more than 45 years and less than 65 years of age
2.Subjects who contain 130 mmHg <= systolic blood pressure <= 159 mmHg or 85 mmHg <= diastolic blood pressure <= 99 mmHg
3.Subjects equal to less than 30 kg/m^2 of BMI
4.Possible study volunteer to visit
5.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 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 452-1Toiso,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
2017 Year 09 Month 14 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
2017 Year 07 Month 18 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 12 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
2017 Year 08 Month 21 Day
Last modified on
2018 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032448

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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