Healthy volunteers
Conditions
Interventions
Intake of test food 1 for 2 weeks
Intake of test food 2 for 2 weeks
Intake of test food 3 for 2 weeks
Intake of test food 4 for 2 weeks
Intake of placebo for 2 weeks
Sponsors
Morishita Jintan Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects whose age is 20 years or more and less than 65 years 2) Subjects whose defecation frequency is between 3 and 5 times per week 3) Subjects whose average of Bristol stool scale for a week is 3 or less 4) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Exclusion criteria
Exclusion criteria: 1) Subjects who meet the diagnostic criteria for chronic constipation according to chronic constipation medical treatment guidelines 2017 2) Subjects receiving a medical treatment for serious hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders 3) Subjects who have the possibility of developing allergic symptoms by the test food 4) Subjects who take Foods for Specified Health Uses or Foods with Function Claims labeled the intestine function 5) Subjects who take a large amount of foods which would affect the intestine function 6) Female subjects who are pregnant or lactating, or intending to become pregnant during the study 7) Subjects who have collected more than 200 mL of blood within 1 month or more than 400 mL within 3 months prior to the start of the present study (e.g. donated blood) 8) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who are currently taking part in another clinical study 9) Subjects deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| Defecation time, Stool volume, Bristol stool scale, Stool color, Stool odor, Refreshing feeling after defecation, Feeling of rectal fullness, Straining during defecation, Ease of defecation, Pain during defecation, Good feeling after defecation, Painful urge to defecate, Satisfaction with defecation, Feeling of stool accumulation in the abdomen , Abdominal discomfort, Abdominal distention or bloating, Feeling of heaviness in the abdomen, Feeling of refreshment in the abdomen, Flatus frequency | — |
Countries
Japan
Contacts
Public ContactTomohiro Sugino
Soiken Inc. R&D Division
Outcome results
None listed