Hyperglycemia
Conditions
Interventions
Control food (placebo): Ingestion of 3 folds dose of recommended daily intake for test food, for 4 weeks.
Test food: Ingestion of 3 folds dose of recommended daily intake for test food, for 4 weeks.
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects giving written informed consent 2. Healthy men and women of 20 to 64 years age 3. Fasted blood glucose levels were 125 mg/dL or less and blood HbA1c levels were 6.4% or less at the screening period
Exclusion criteria
Exclusion criteria: 1. Subjects with milk allergy or lactose intolerance 2. Subjects who were diagnosed with diabetes by the screening test 3. Sever systemic diseases affecting the results of this study 4. Subjects who have chronic illness and who take medication everyday 5. Subjects who were judged unsuitable as subjects by clinical examination at the screening test 6. Subjects who donated blood of more than 200 mL within a month or more than 400 mL within 3 months 7. Subjects who drink a lot of alcohol 8. Subjects who have been drug dependency 9. Subjects who participated in other clinical trials within one month before the agreement of participants in this study 10. Subjects in pregnancy or in nursing 11. Subjects who are judged as unsuitable for the study by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematologic test, blood biochemistry test, urine analysis, blood pressure/pulsation, weight/body mass index, doctor's questions, and adverse event (Evaluate at points of 2 week and 4 week of ingestion and 2 weeks after the end of ingestion period) | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Sales department
Outcome results
None listed