Healthy adults
Conditions
Interventions
Intake of the test food for 12 weeks (6 tablets/day)
Intake of the placebo food for 12 weeks (6 tablets/day)
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Healthy males and females aged 20 to 64 years 2)Subjects whose fasting blood glucose levels are less than 125 mg/dL and HbA1c are 5.6% to 6.4% 3)Subjects who take 3 meals a day 4)Subjects who don't habitually take much alcohol 5)Subjects who have understood the purpose and contents of the study and agree to participate by signing the written informed consent 6)Subjects who are not diagnosed disease by the doctor in charge
Exclusion criteria
Exclusion criteria: 1)Subjects who are or have a history of diabetes 2)Subjects who habitually take medecine which may affect blood glucose level 3)Subjects who can't stop taking supplements which may affect blood glucose level 4)Subjects who have allergy to the test food 5)Subjects who have kidney disease, liver disease, heart disease, respiratory disease, endocrine disease, or other metabolic disease 6)Subjects who have chronic disease and habitually take medecine 7)Subjects who have digestive disease or a history of digestive surgery 8)Subjects who have severe diarrehea 7 days before the screening tests 9)Subjects who are considered as an inappropriate candidate based on the screening tests by the doctor in charge 10)Subjects who are diagnosed anemia 11)Subjects who donated blood of over 200 mL in the past 1 month or over 400 mL in the past 3 months 12)Subjects who are or have a history of alcoholism or drug addict 13)Shift worker or midnight shift worker 14)Subjects who are planning to participate in other clinical study during the study period or have participated in the past 1 month 15)Subjects who are pregnant, lactating, or planning to get pregnant 16)Subjects who are considered as an inappropriate candidate for other reasons by the doctor in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood glucose level, Blood insulin level, HOMA-IR, 1,5-AG, Body weight, BMI, Triglycerides | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Sales department
Outcome results
None listed