Healthy adults
Conditions
Interventions
Test food A : Take 1 capsule once daily after dinner for 12 weeks.
Test food B : Take 1 capsule once daily after dinner for 12 weeks.
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females from 20 to 64 years of age. 2. Subjects with a tendency for constipation (three to five times of defecation per weeks) or with normal defecation (more than 5 times of defecation per weeks). 3. Subjects who can make self-judgment and are voluntarily giving written informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects who regularly take oral medicine (especially laxatives, antiflatulents, laxatives, etc. that affect bowel movements). 2. Subjects who have a history of Serious diseases such as diabetes, kidney/liver disease or heart disease, and/or thyroid diseases, adrenal diseases, and other metabolic diseases or who is under medical treatment. 3. Subjects who have chronic disease and is under medication. 4. Subjects with a digestive organ disease or surgical history who has an influence on digestive absorption and defecation (Excluding appendicitis). 5. Subjects who are suffering from other serious diseases. 6. Subjects who are not able to stop ingesting foods containing live bacteria such as lactic acid bacteria, bifidobacteria, and bacillus subtilis natto, foods fortified with oligosaccharides and dietary fiber, health foods that are said to be good for improving constipation, foods containing large amounts of sugar alcohol, during the study period. 7. Subjects who are consuming large amounts of alcohol (abouts 40 g or more in terms of pure alcohol) on a daily basis. 8. Subjects who have a history of drug dependence or alcohol dependence or have a current medical history. 9. Subjects who have food and medicine allergy. 10. Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period. 11. Subjects who participate in other clinical trials, who have participated in other tests within one month of obtaining consent, or who are willing to participate. 12. Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Medical interview/Subjective and Objective symptom 2. Body weight (BMI) 3. Blood pressure/Pulse rate 4. Clinical examination | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Clinical Trial Management department
Outcome results
None listed