Healthy adults
Conditions
Interventions
Take test food A once a day, 1 capsule, for 2 weeks.
Take test food B once a day, 1 capsule, for 2 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 who usually have two or more meals a day. 3.Subjects with constipation tendency at three to five times of defecation per weeks. 4.Subjects with a tendency for hard stool. 5.Subjects who can make self-judgment and are voluntarily giving written informed consent.
Exclusion criteria
Exclusion criteria: 1.Subjects who fall in more than over a quarter to Bristol stool scale 1 or 2. 2.Subjects who are taking medicine. 3.Subjects who are taking health foods which are said to improve constipation at the point of screening examination. 4.Subjects who are having been taken antibacterial drug within 2 weeks at the point of before screening examination. 5.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 a large amount of sugar alcohol, and/or taking antibacterial drugs, laxatives, intestinal regulators, constipation drugs during the study period. 6.Subjects who are consuming large amounts of alcohol on a daily basis. 7.Subjects with a digestive organ disease or surgical history who has an influence on digestive absorption and defecation. 8.Subjects with chronic illness who regularly use medicine (including IBS and IBD) 9.Subjects who have food and medicine allergy. 10.Subjects who are affected from or under treatment of serious disease. 11.Subjects who are judged to be unsuitable as a subject from an answer of a subjective background questionnaire. 12.Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period. 13.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. 14.Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Defecation days 2. Fecal amount 3. Stool consistency (Bristol stool scale) 4. Straining during defecation 5. Pain during defecation 6. Feeling of incomplete evacuation after defecation 7. Abdominal bloating 8. Fecal water content 9. QOL questionnaire | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Sales department
Outcome results
None listed