Adult males and females
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Males and females aged between 20 and 60 (2) Subjects who can agree to participate in this study (3) Subjects who can go to hospital on designated day (4) Subjects whose HbA1c value is 5.6 to 7.0% (5) Subjects whose blood pressure is 120-145 / 80-95mmHg (6) Appropriate admission to the study by the doctor
Exclusion criteria
Exclusion criteria: (1) Subjects routinely taking medicine (2) Subjects who have under treatment or a history of serious disease. (Mental illness, sleep disorder, liver, kidney, heart, lung, blood, etc.) (3) Subjects who have under treatment or a history of serious disease of the digestive tract. (4) Subjects who donated blood (blood donation etc.) exceeding 200 mL within 1 month or 400 mL within 3 months (5) Subjects who have experienced bad mood or poor physical condition due to blood sampling (6) Subjects having possibilities for emerging allergy related to the current study (7) Subjects who drink much alcohol (8) Subjects who may drastically change their lifestyle during the study (such as long trips) (9) Subjects who are pregnant, breastfeeding or have the possibility of becoming pregnant (10) Subjects who have participated in other clinical study within the last 3 month or have plan to participate other clinical studies (11) Subjects who works for a company where the person or family develops, manufactures or sells health / functional foods and cosmetics (12) Subjects who are judged as ineligible by the clinical investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose and HbA1c Blood pressure | — |
Secondary
| Measure | Time frame |
|---|---|
| Body weight / Body fat / BMI Activity Glycoalbumin Insulin and HOMA-R index Blood lipids (triglyceride, total cholesterol, HDL, LDL cholesterol) Uric acid level Defecation frequency and days Adverse event | — |
Countries
Japan
Contacts
Welby Inc. Research Development Office