Unique ID issued by UMIN | UMIN000034025 |
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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 |
Safety confirmation study by overdose of a rice bran peptide containing foods.
- Randomized placebo controlled study-
Safety confirmation study by overdose of a rice bran peptide containing foods.
Safety confirmation study by overdose of a rice bran peptide containing foods.
- Randomized placebo controlled study-
Safety confirmation study by overdose of a rice bran peptide containing foods.
Japan |
Persons with normal(including high-normal blood pressure) or mild hype
Adult |
Others
NO
To investigate the safety of overdose for 4 weeks of a rice bran peptide containing foods.
Safety
-
<Safety>
Side effect incidence, Adverse event incidence, clinical examination items, physical measurement items(excluding height) and physiological examination items
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Rice bran peptide non-formulated food, 4 weeks
Rice bran peptide-containing food, 4 weeks
35 | years-old | <= |
65 | years-old | > |
Male and Female
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
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.
60
1st name | |
Middle name | |
Last name | Motonobu Matsumoto |
Sunstar Inc.
General Manager R&D
3-1, Asahimachi, Takatsuki, Osaka,Japan
072-693-3061
motonobu.matsumoto@jp.sunstar.com
1st name | |
Middle name | |
Last name | Yoshitaka Hatakeyama |
New Drug Research Center, Inc.
Clinical Research Dept.
452-1Toiso,Eniwa-shi,Hokkaido, Japan
0123-34-0412
y-hatakeyama@ndrcenter.co.jp
Sunstar Inc.
Sunstar Inc.
Profit organization
NO
2018 | Year | 09 | Month | 07 | Day |
Unpublished
Completed
2018 | Year | 08 | Month | 09 | Day |
2018 | Year | 09 | Month | 21 | Day |
2018 | Year | 09 | Month | 04 | Day |
2019 | Year | 03 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038289
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