Healthy Japanese
Conditions
Interventions
Duration: Eight weeks Test product: Chewable tablet containing Lactococcus cremoris subsp. cremoris YRC3780 powder Administration: Take one tablet once a day with water in the morning (within two ho
Sponsors
Yotsuba Milk Products Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Individuals aged >= 60 at the time of agreement to participate in this study 3. Men whose body weight is >= 50.1 kg, women whose body weight is >= 37.6 kg 4. Individuals whose BMI is >= 17.6 kg/m2 and =< 29.9 kg/m2 5. Individuals who are able to discontinue the intake of other lactic acid bacteria-related foods and oligosaccharides during this study 6. Healthy individuals
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, gastrointestinal disorder, congenital disease, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) or supplements 6. Individuals who are allergic to medicines or foods related to the test product 7. Individuals who have diarrhea by consuming yogurt 8. Individuals who have used expectorants or antibiotics that affect IgA, or medicines that affect intestinal function, within one month prior to this study (those who use them during this study will be discontinued from participation) 9. Individuals who are diagnosed with dementia 10. Individuals who have been diagnosed with undernutrition 11. Individuals whose saliva volume is less than 1 mL even after more than 3 minutes of collection, or whose salivary flow rate is less than 100 mg per minute 12. Individuals who are pregnant, lactating, or planning to become pregnant during this study 13. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 14. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Measured value of salivary immunoglobulin A (IgA) secretory rate at eight weeks after the intervention (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Measured value of salivary IgA secretory rate at four weeks after intervention (4w) 2. Change and percentage change in salivary IgA secretory rate from screening to 4w and 8w 3. Measured values of saliva volume and salivary IgA level at 4w and 8w, as well as changes and percentage changes from screening | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed