UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034025
Receipt No. R000038289
Scientific Title Safety confirmation study by overdose of a rice bran peptide containing foods. - Randomized placebo controlled study-
Date of disclosure of the study information 2018/09/07
Last modified on 2019/03/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.