Healthy Japanese
Conditions
Interventions
Duration: Eight weeks Test food: Chewable tablet containing Lactococcus lactis subsp. cremoris YRC3780 powder Administration: Take one tablet once a day with water, chewing, or dissolving in the mou
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic Kanagawa Dental University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Individuals aged 60 or more at the time of agreement to participate in this study 3. Men whose body weight is 50.1 kg or more, women whose body weight is 37.6 kg or more 4. Individuals whose BMI are 17.6 kg/m2 or more and 29.9 kg/m2 or less 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) and supplements 6. Individuals who are allergic to medicines or foods related to test products 7. Individuals who have diarrhea by consuming yogurt 8. Individuals who have used expectorants or antibiotics that affect IgA or medicines that affect intestines within one month prior to this study (Individuals who use them during this study will be excluded from this study) 9. Individuals who are diagnosed with dementia 10. Individuals who have been diagnosed with undernutrition 11. Individuals who are pregnant, lactating, or planning to become pregnant during this study 12. 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 13. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of salivary IgA secretory rate at eight weeks after intervention (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of salivary IgA secretory rate at four weeks after intervention (4w) 2. The amount and rate of changes from screening (before intervention) of salivary IgA secretory rate at 4w and 8w 3. The measured value of salivary spermidine at 8w 4. The measured value of salivary spermidine at 4w 5. The amount and rate of change from screening of salivary spermidine at 4w and 8w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed