Persons with high-normal blood pressure or mild hype
Conditions
Interventions
Rice bran peptide non-formulated food, 12 weeks
Rice bran peptide-containing food, 12 weeks
Sponsors
Sunstar Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Males and females equal to or more than 45 years and less than 65 years of age 2.Subjects who contain 130 mmHg <= systolic blood pressure <= 159 mmHg or 85 mmHg <= diastolic blood pressure <= 99 mmHg 3.Subjects equal to less than 30 kg/m^2 of BMI 4.Possible study volunteer to visit 5.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 |
|---|---|
| <Efficacy> systolic blood pressure,diastolic blood pressure | — |
Secondary
| Measure | Time frame |
|---|---|
| <Safety> Side effect incidence, Adverse event incidence, clinical examination items, and physiological examination items | — |
Countries
Japan
Contacts
Public ContactYoshitaka Hatakeyama
New Drug Research Center, Inc. Clinical Research Dept.
Outcome results
None listed