No(Borderline diabetes)
Conditions
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)(Healthy) males and females aged 20 to 64 years old. (2)Subjects whose fasting blood glucose level are from 110 mg/dL to 125 mg/dL or 2-hour glucose value in a 75 g oral glucose tolerance test are from 140 mg/dL to 199 mg/dL, and who are judged as borderline diabetes by the investigater. (3)Subjects who don't habitually consume a large amount of alcohol. (4)Subjects who can make self-judgment and voluntarily give written informed consent.
Exclusion criteria
Exclusion criteria: (1)Subjects whose fasting blood glucose level are 126 mg/dL and over, or 2-hour glucose value in a 75 g oral glucose tolerance test are 200 mg/dL and over. (2)Subjects who use oral medications affecting blood glucose. (3)Subjects who can't stop using supplements and/or functional foods(including Food for Specified Health Uses or Foods with Function Claims) affecting blood glucose during test periods. (4)Subjects who have declared allergic reaction to test foods or ingredients contained in loading foods. (5)Subjects who are diagnosed as diabetes based on the results of screening test. (6)Subjects who contract, are under treatment for or have a history of serious diseases(e.g., diabetes, kidney disease, liver disease, and heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder. (7)Subjects who have a chronic disease and use medications continuously. (8)Subjects who have a history of digestive disease affecting digestion and absorption. (9)Subjects who are judged as unsuitable for the current study based on the results of screening test. (10)Subjects who are diagnosed as anemic and not suitable for frequent collection of blood. (11)Subjects who have had diarrhea within the last one week prior to the screening test. (12)Subjects who have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study. (13)Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. (14)Subjects who are planning to participate in other clinical studies. (15)Subjects who are planning to become pregnant after informed consent for the current study, are pregnant or lactating. (16)Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postprandial blood glucose AUC | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Sales department
Outcome results
None listed