Healthy adults
Conditions
Interventions
Duration: 4 weeks Test material: ALBEX Dose: Drink 10 mL twice a day Administration: To drink ALBEX with a cup of water before breakfast and dinner
Duration: 4 weeks Test material: Placebo Dose
Sponsors
ORTHOMEDICO, Inc.
Seishin-kai Medical Association Inc, Takara Medical Clinic.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adults 2. Persons who defecate two to five times per week
Exclusion criteria
Exclusion criteria: 1. Subjects who have at least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who being treated for at least one of following diseases: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Subjects who currently take medicines (include herbal medicines) 4. Subjects who currently take Food for Specified Health Uses, Foods with Functional Claims, yogurt, and/or bifidobacteria and lactic acid bacteria beverage, bifidobacteria and lactic acid bacteria contains food 5. Subjects who are allergic to medicines or foods related to the test materials of this trial, particularly allergic to soy 6. Subjects who currently take supplements or nutrition enrichments 7. Subjects who are pregnant, lactating, or planning to get pregnant during the trial period 8. Subjects who have enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial 9. Subjects are decided as unsuitable for participating in this trial by physician for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Total intestinal bacterial count *1 Perform the test at 0 week and at 2 and 4 weeks after the ingestion | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The Japanese version of Constipation Assessment Scale MT version (CAS-MT) *1 Answer CAS-MT at 0 week and at 2 and 4 weeks after the ingestion 2. Stool form scale *2 Answer stool form scale at 0 week and at 2 and 4 weeks after the ingestion 3. Bowel movement diary *3 Recording about the defecation every day 4. Analysis of peripheral blood {Diacron-Reactive Oxygen Metabolites (d-ROM), Bone Specific Alkaline Phosphatase (BAP)} *4 Perform the test at 0 week and 4 weeks after the ingestion 5. Stool analysis {Stool IgA, organic acids (succinic acid, lactic acid, formic acid, acetic acid, propionic acid, isobutyric acid, butyric acid, isovaleric acid, valeric acid), ammonia} *5 Analyze at 0 week and at 2 and 4 weeks after the ingestion (Stool IgA: Analyze at 0 week and 4 weeks after the ingestion) | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO, Inc. R&D Department
Outcome results
None listed