Healthy male adults
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Subjects who are not suffering from a chronic constipation (number of stool is more than 5 times/ week) 2) Subjects who are competent to consent. 3) Subjects who are competent to keep the rules of the study and are able to report self-condition. 4) Subjects who are judged eligible by the investigator in several series of medical interview conducted prior to study.
Exclusion criteria
Exclusion criteria: 1) Subjects who have an inappropriate clinical history for efficacy and safety assessment in the study (such as drug abuse, alcoholism, and the disease of heart, liver, kidney, lungs, eye, blood etc). 2) Any history for allergy against any components in trial food. 3) Subjects who have a current and/or past clinical history which would occur an obstruction in GI tract. 4) Subjects who are daily taking any foods which will effect on bowel movement (incl. Functional display food, Food for specified health use, Supplements and so on) 5) Subjects who are inadequate for enrollment judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean total colonic transit time | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean left colonic transit time Mean right colonic transit time Mean rectum transit time Mean Rectosigmoid colonic transit time Condition of stool defecation Output volume Frequency Color Smell Stool property (Bristol scale) Feeling after defecation Frequency of fart Safety | — |
Countries
Japan
Contacts
Showa University School of Medicine Department of Clinical Pharmacology