Males and females aged 20 to 64 years old
Conditions
Interventions
1. Single intake of the test food. 2. Washout period more than two days. 3. Single intake of the control food.
1. Single intake of the control food. 2. Washout period more than two days. 3. Sing
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Males and females aged 20 to 64 years old (2)Subjects with borderline results in the oral glucose tolerance test from the first phase of the preliminary check (whose blood glucose levels meet any of the following criteria) The range of fasting blood glucose levels is from 110 to 125 mg/dL. The blood glucose level after 60 minutes of the oral glucose tolerance test is 180 mg/dL or higher. The range of blood glucose levels after 120 minutes of the oral glucose tolerance test is from 140 to 199 mg/dL . (3)Subjects showing hyperglycemia after the dietary load in the second phase of the preliminary check (with a blood glucose Cmax of 160 mg/dL or higher). (4)Subjects whose fasting blood glucose levels are 125 mg/dL or lower in the first phase of the preliminary check. (5)Subjects whose HbA1c levels are 6.4% or lower. (6)Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: (1) Subjects who are having Food for Specified Health Uses (FOSHU), Foods with functional claims and/or health food, including supplements, (including suppression of blood glucose level elevation, etc.) which might affect this study, three times or more a week. (2) Subjects who are taking medications (e.g., diabetes medications) that may affect this study. (3) Subjects with severe hay fever symptoms who are taking oral medications, or who may take them during this study period (excluding those using only nasal sprays or eye drops). (4) Subjects who are participating, participated within the last four weeks before this study, or are planning to participate another clinical study of medication or health food. (5) Subjects who have extremely disheveled dietary habits. (6) Subjects who have disheveled lifestyle (e.g., shift workers and night workers). (7) Heavy drinkers (8) Subjects who currently smoke, or have had a smoking habit from one year prior to the start of this study up to the present. (9) Subjects who are undergoing a low-carbohydrate diet. (10) Subjects with a BMI of 30.0 kg/m2 or higher in the first phase of the preliminary check. (11) Subjects with abnormal thyroid function in the second phase of the preliminary check. (12) Subjects who have been diagnosed as anemia or have subjective symptoms of anemia. (13) Subjects who have past and present medical history of serious diseases of heart, liver, kidney, digestive organs, and/or thyroid gland, etc. (14) Pregnant women, lactating women, or women who want to get pregnant during this study. (15) Subjects who are allergic to drugs or foods. (16)-(20) Subjects who have donated a lot of whole blood and/or blood components within the last 12 months prior to this study. (21) Subjects who have been determined ineligible by principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve of blood glucose levels | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood glucose levels Serum insulin levels Plasma pancreatic glucagon levels Plasma GLP-1 levels Plasma GIP levels Serum free fatty acid levels Matsuda index Insulinogenic index | — |
Countries
Japan
Contacts
Public ContactMidori Natsume
Meiji Holdings CO., Ltd. Research Team 3 Wellness Science Labs
Outcome results
None listed