Persons with high-normal blood pressure or mild hypertension
Conditions
Interventions
a rice bran peptide non-containing foods, 12 weeks
a rice bran peptide containing foods (500mg/day), 12 weeks
a rice bran peptide containing foods (1000mg/day), 12 weeks
a rice bran peptide containing
Sponsors
New Drug Research Center, 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 more than 130 mmHg and less than 159 mmHg systolic blood pressure or more than 85 mmHg less than 99 mmHg diastolic blood pressure 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 Subjects who have marked impairment of liver,kidney,heart,lung,endocrine,metabolism,nerve,or consciousness, or have DM. 2 Individual given surgery within 2 months before the final examination. 3 Medicine user for hyperglycaemia,lipidemia,or hypertension. 4 Individual intakes the food for specific use of health authorized the government and foods with function claims. 5 Individual experienced unpleasant feeling by drawing blood in the past. 6 Individual donated 200 ml or more of blood within a month prior to the study. 7 Individual changed weight 2 kg or more within 1month before the trial. 8 Night worker and shift worker. 9 Individual plans business trip for 10 consecutive days or more. 10 Individual can't intake test meal. 11 Individual had allergy against any constituents in the test meal. 12 Individual can not conform to control of alcohol(equivalent of 500 ml of beer per day). 13 Individual can not conform to record of"life diary"every day during the period of the test. 14 Individual can not conform to record of daily diet for 9 days(3 days x 3 times). 15 Individual cannot allow operator to consult his/her data of the past health check. 16 Individual have already participated other clinical trial and will participate. 17 Individual can not agree with preliminary explanation. 18 Pregnant women or breast-feeding women. 19 Individual who was judged ineligibles by clinician in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| systolic blood pressure and diastolic blood pressure at 4,8 and 12 weeks after intake | — |
Secondary
| Measure | Time frame |
|---|---|
| count of adverse event average of adverse event count of adverse effect average of adverse effect | — |
Countries
Japan
Contacts
Public ContactYoshitaka Hatakeyama
New Drug Research Center, Inc. Clinical Research Dept.
Outcome results
None listed