Healthy subjects
Conditions
Interventions
Intake of 4 packages of the test food per day for 12 weeks.
Intake of 4 packages of the placebo food per day for 12 weeks.
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Aged between 20 and 59 years old at consent acquisition. (2)Subjects whose fasting blood glucose is 100-125 mg/dL or whose blood glucose is 140-199mg/dL (at 120 minutes of glucose tolerance test). (3)Subjects who understand the study procedures and agree to participate in the study by giving informed consent prior to the study.
Exclusion criteria
Exclusion criteria: (1)Subjects using medical products. (2)Subjects who have a habit of ingesting medicine, health-promoting foods, foods for specified health uses, health foods that may affect this study. (3)Females who are pregnant or lactating, or who could become pregnant or lactating during test period. (4)Subjects who have a history of heart failure,liver failure, kidney failure, or digestive system disease. (5)Subjects who excessively take alcohol. (6)Subjects whose eating habits and rhythm of daily life are irregular (Shifts workers, late-night workers). (7)Subjects who have allergy for medicine and foods. (8) Subjects who are participating in other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate in other clinical tests. (9) Subjects who donated over 200mL blood and/or blood components within the last one month. (10) Males who donated over 400mL blood within the last three months. (11) Females who donated over 400mL blood within the last four months. (12) Males who will be collected over 1200 mL of blood when the planned sampling volume in this study is added to the volume collected within the last 12 months. (13) Females who will be collected over 800 mL of blood when the planned sampling volume in this study is added to the volume collected within the last 12 months. (14)Subjects who are not eligible for this study for some medical reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting blood glucose | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunoreactive insulin, Homeostasis model assessment of insulin resistance, Incremental blood glucose area under the curve. | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Plan Sales Department
Outcome results
None listed