Male and female who are aged 20 years and older and who have high HbA1c levels
Conditions
Interventions
Intake 2 packages of resistant maltodextrin a day for 24 weeks
Intake 2 packages of dextrin a day for 24 weeks
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Males and females aged 20 and older. (2) Subjects whose HbA1c levels are equal to or higher than 6.0%. (3) Subjects who receive explanation for this study and voluntary give written informed consent.
Exclusion criteria
Exclusion criteria: (1) Subjects who are diagnosed as diabetes and receiving treatment. (2) Subjects who constantly take oral medicines, functional foods and/or supplements that have a possibility to affect the test results. (3) Females who are pregnant or lactating, and females who have possibility of pregnancy. (4) Subjects who donated blood and/or blood components more than 200 mL within 4 weeks prior to the test. (5) Males who donated blood and/or blood components more than 400 ml within 12 weeks prior to the test. (6) Females who donated blood and/or blood components more than 400 ml within 16 weeks prior to the test. (7) Males who were collected blood and blood components more than 1200 ml within 12 months prior to the test when planned blood sampling amount of this test is added. (8) Females who were collected blood and blood components more than 800 ml within 12 months prior to the test when planned blood sampling amount of this test is added. (9) Subjects who are participating in other clinical tests, and/or subjects who participated in other clinical tests within 4 weeks prior to the test. (10) Subjects who consume excessive amount of alcohol or smoke heavily (more than 21 cigarettes a day). (11) Subjects who have extremely irregular dining habits, and/or subjects who work midnight or irregular shifts. (12) Subjects who falls under any of the following criteria. (a) Subjects who have heart disease, liver disease, or kidney disease (including the complication of other diseases). (b) Subjects who have medical history of cardiovascular diseases. (c) Subjects who are allergic to the test foods. (13) Subjects who are judged as unsuitable for this study by principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1)Efficacy: HbA1c (2)Safety: The incidence of side effects | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Efficacy: OGTT, GA, 1.5-AG, GLP-1, intestinal flora (2)Safety: The incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactKazuyoshi shibata
CPCC Company Limited Plan Sales Department
Outcome results
None listed