UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034025
Receipt number 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 09:24:50

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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 or person

Institute

Sunstar 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


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

Value
https://center6.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