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UMIN-CTR Clinical Trial |
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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 |
Basic information | ||
Public title | Safety confirmation study by overdose of a rice bran peptide containing foods.
- Randomized placebo controlled study- |
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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- |
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Scientific Title:Acronym | Safety confirmation study by overdose of a rice bran peptide containing foods. | |
Region |
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Condition | ||
Condition | Persons with normal(including high-normal blood pressure) or mild hype | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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. |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Sunstar Inc. | ||||||
Division name | General Manager R&D | ||||||
Zip code | |||||||
Address | 3-1, Asahimachi, Takatsuki, Osaka,Japan | ||||||
TEL | 072-693-3061 | ||||||
motonobu.matsumoto@jp.sunstar.com |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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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 |