Healthy Japanese subjects
Conditions
Interventions
Duration: Two weeks Test beverage: Lactic fermenting beverage Administration: Drink one bottle (100 ml) per day *If you forget to drink the test beverage, drink it as soon as you remember within
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. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who defecate three to five times per week 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects who have relatively few defecation frequency during a week before screening
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who 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. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 5. Subjects who take in daily use or cannot stop taking the food containing viable bacteria (such as natto, yogurt, and fermented food), oligosaccharide-fortified food, or lactic fermenting beverage and/or food 6. Subjects who currently taking medications (including herbal medicines) and supplements 7. Subjects who are allergic to medicines and/or the test beverage related products 8. Subjects who are pregnant, lactation, or planning to become pregnant 9. Subjects who suffer from COVID-19 10. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 11. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Defecation frequency in period B*1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Defecation frequency in period A*1 2. Numbers of defecation days and amount of defecation in period B*1 3. Stool shape, stool smell, and exhilarating feeling of defecation in period A and B*1 4. The cumulative number of days with common cold symptoms*2 during the intervention period per subject 5. The diversity index (Chao 1 index, Shannon index), the occupancy rate of bacteria in the stool, immunoglobulin A (IgA) in the stool, and the score of The Japanese Version of the Constipation Assessment Scale (CAS) at two weeks after consumption (2w) 6. Each item of CAS at 2w *1 Period A: 1st week of the start of consumption Period B: 2nd week of the start of consumption *2 The common cold symptom is defined as the onset of more than one of the following symptoms: whole body malaise, chilliness, feverishness, fatigue, sneezing, nasal discharge, blocked nose, throat pain, cough, joint pain, and muscle pain | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed