UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023982 |
|---|---|
| Receipt number | 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 15:02:04 |
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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.
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
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
y-hatakeyama@ndrcenter.co.jp
Sponsor or person
Institute
New Drug Research Center, Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027608
