Healthy Japanese subjects
Conditions
Interventions
Duration: Four weeks Test food: Tablets containing high levels of lactic acid bacteria Administration: Take one tablet per day with water after dinner within 30 minutes * Daily dose should be ta
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. Male or female 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who defecate three to five times per week 6. Subjects who are aware that they easily feel fatigue and get sick. 7. Subjects who are judged as eligible to participate in the study by the physician 8. Subjects who have relatively few defecation frequency during a week before Scr
Exclusion criteria
Exclusion criteria: Subjects (who) 1.undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2.have a pacemaker or an implantable cardioverter defibrillator 3.currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4.take "Foods for Specified Health Uses", "Foods with Functional Claims", foods containing viable fungi such as natto, yogurt, and fermented foods, foods fortified with oligosaccharides and dietary fiber, foods containing high amounts of sugar alcohol, food/beverage containing lactic acid bacteria, or other functional food/beverage in daily use and unable to quit the intake during the test period 5.regularly use medicines related to bowel movement, such as intestinal regulator and laxatives 6.currently taking medicines (include herbal medicines) and supplements 7.affected from pollen allergy 8.have received vaccination for infectious diseases such as influenza within a year 9.are smokers, or started smoking cessation within a year 10.drink an excess of alcohol *weekly average of alcohol intake is more than 60 g/day [Reference materials for the promotion of Health Japan 21 (the second term)] 11.are planning to go abroad or have a job transfer during this trial 12.are allergic to medicines and/or the test food related products. Particularly, lactic acid bacteria, vitamin D, starch, sucrose fatty acid ester, or hydroxypropylmethylcellulose capsule 13.are lactating, pregnant, or intending to become pregnant 14.have been enrolled in other clinical trials within the last 3 months before the invitation to participate in this trial, or plan to participate in another trial during this trial 15.are judged by the principal investigator as ineligible to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured value of defecation frequency at period VI | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amounts of changes from periods I or II of defecation frequency in period VI 2. The measured values and amounts of changes from periods I or II of defecation frequency in periods III to V 3. The measured values and amounts of changes from periods I or II of defecation days and amount of defecation in periods III to V 4. The measured values of shape and smell of stool and exhilarating feeling in periods III to VI 5. The measured values and amounts of changes from screening (before consumption; Scr) of CAS score of CAS-MT at two and four weeks after consumption (2w, 4w) 6. The measured values of scores for each item of CAS-MT at 2w and 4w 7. The measured values and amounts of changes from Scr of the following items at 4w: total number of bacteria, numbers of lactic acid bacteria, Bifidobacterium, and Clostridium perfringens, salivary immunoglobulin A (s-IgA), scoring of immunological vigor, T lymphocyte age (upper limit), the numbers of T cells, naive T cells, B cells, NK cells, and CD8+CD28+T cells and the ratios of CD4+T cells to CD8+T cells and naive T cells to memory T cells 8. The measured values of the following items at 4w: immunological grade, the scores of T cells, CD8+CD28+T cell ratios, ratio of CD4+T cells to CD8+T cells, naive T cells, ratio of naive T cells to memory T cells, B cells, and NK cells 9. The cumulative number of days with each symptom listed on the diary report (#) and the common cold symptoms (*) during the intervention period per group 10. The cumulative number of days with each symptom listed on the diary report (#) and the common cold symptoms (*), and the maximum duration of the days with common cold symptoms (*) during the intervention period per subject #: Feverishness, nasal discharge, blocked nose, throat pain, cough, sneezing, whole body malaise, muscle pain, joint pain, chilliness, fatigue, physical condition, and headache *: The common cold symptom is defined as the onset of any one of #. | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed