Healthy Japanese
Conditions
Interventions
Duration: Two weeks Test food: Lactic acid bacteria
Duration: Two weeks Test food: Placebo
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose defecation frequency is three to five times in period 1
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and 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, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who take yogurt, lactic acid bacteria beverages, natto, or kimchi at least four times a week 6. Individuals who are taking or using medications (including herbal medicines) and supplements 7. Individuals who are allergic to medicines and/or foods related to the test products 8. Individuals who are pregnant, lactating, or planning to become pregnant during this study 9. 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 another study during this study 10. 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 defecation frequency in period 3 (8~14 days after consumption) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of defecation frequency in period 2 (1~7 days after consumption) 2. The measured values of numbers of defecation days and amount of defecation in period 2 and 3 3. Individuals whose stool shape, stool smell, and exhilarating feeling of defecation improved by one or more scales in period 2 and 3 compared to period 1 (7 days prior to screening) 4. The measured values of Bifidobacterium, Lactobacillus, Streptococcus, Enterococcus, Firmicutes, Bacteroidetes, Actinobacteria, Proteobacteria, Shannon's diversity index, Observed OTUs, Faith's Phylogenetic Diversity, and Chao1 at two weeks after consumption (2w) 5. The measured values of acetic acid, propionic acid, iso-butyric acid, n-butyric acid, iso-valeric acid, n-valeric acid, lactic acid, succinic acid, and formic acid at 2w 6. The measured value of Constipation Assessment Scale (CAS) score in the CAS Middle Term version (CAS-MT) at 2w 7. Individuals whose CAS-MT questionnaire response improved by one or more scales in period 2 and 3 compared to period 1 | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed