Persons with normal(including high-normal blood pressure) or mild hype
Conditions
Interventions
Rice bran peptide non-formulated food, 4 weeks
Rice bran peptide-containing food, 4 weeks
Sponsors
Sunstar Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - | — |
Secondary
| Measure | Time frame |
|---|---|
| <Safety> Side effect incidence, Adverse event incidence, clinical examination items, physical measurement items(excluding height) and physiological examination items | — |
Countries
Japan
Contacts
Public ContactYoshitaka Hatakeyama
New Drug Research Center, Inc. Clinical Research Dept.
Outcome results
None listed