Safety confirmation study by overdose of a rice bran peptide containing foods. - Randomized placebo controlled study
- Conditions
- Persons with normal(including high-normal blood pressure) or mild hype
- Registration Number
- JPRN-UMIN000034025
- Lead Sponsor
- Sunstar Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -
- Secondary Outcome Measures
Name Time Method <Safety> Side effect incidence, Adverse event incidence, clinical examination items, physical measurement items(excluding height) and physiological examination items