Healthy adults
Conditions
Interventions
Consumption of the test product for 24 weeks
Consumption of the placebo for 24 weeks
Sponsors
KAGOME CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Japanese male and female participants aged >= 18 and < 64 years with HbA1c levels within the normal range or slightly elevated (HbA1c < 6.5%) who do not meet any exclusion criteria, express willingness to participate in the study, and provide informed consent online
Exclusion criteria
Exclusion criteria: 1. Individuals receiving treatment or medication for diabetes 2. Individuals who habitually consume Foods for Specified Health Uses or Foods with Functional Claims intended to suppress postprandial blood glucose elevation at least three times per week 3. Individuals who habitually consume 100% vegetable juice or vegetable-fruit mixed juice at least three times per week 4. Individuals with food allergies to the test beverage 5. Individuals with alcohol hypersensitivity severe enough to make alcohol disinfection difficult 6. Individuals planning to become pregnant or to breastfeed during the study period 7. Individuals with anemia detected on blood testing (Hb < 13.0 g/dL for adult males and Hb < 12.0 g/dL for non-pregnant adult females), or individuals for whom interpretation of HbA1c is considered difficult due to blood donation of >= 200 mL within the past month or >= 400 mL within the past three months 8. Individuals with chronic diseases requiring daily medication 9. Individuals diagnosed with liver cirrhosis or chronic hepatitis B or C 10. Individuals with a history of gastrointestinal surgery (e.g., gastrectomy or bypass surgery) 11. Individuals unable to maintain a stable daily routine, such as those working exclusively night shifts or extreme shift schedules 12. Individuals participating in other clinical studies at the start of this study 13. Individuals deemed unsuitable by the principal investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in HbA1c from before the intervention to 24 weeks after the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| a. The measured value of HbA1c at 24 weeks after the intervention b. The measured value of HbA1c at 12 weeks after the intervention and the change from before the intervention c. The measured values of AST, ALT, gamma-glutamyl transpeptidase, ALP, total bilirubin, and total protein at 12 and 24 weeks after the intervention, and their changes from before the intervention d. The measured values of fasting plasma glucose, 2-hour plasma glucose during OGTT, and Matsuda index at 12 and 24 weeks after the intervention, and their changes from before the intervention e. The measured values of Fatty Liver Index (FLI) and NAFLD Fibrosis Score (NFS) at 12 and 24 weeks after the intervention, and their changes from before the intervention f. The measured values of body weight, BMI, and waist circumference at 12 and 24 weeks after the intervention, and their changes from before the intervention | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO, Inc. R&D Department
Outcome results
None listed