None listed
Conditions
Interventions
Intake test food one capsule a day for four weeks. Receive tests before, two weeks after and four weeks after starting test food intake.
Intake control food one capsule a day for four weeks. Receive t
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Males and females of Japanese aged 20 to 65 years old. (2) Subjects who have troubles because of loose stool and/or constipation. (3) Subjects who receive enough explain of the test, who deeply understanding of the test, and who obtain own consent to participate the test.
Exclusion criteria
Exclusion criteria: (1)Subjects who are given continuous treatment by taking medicines. (2) Subjects who use medicines, food for specified health use, functional foods, health foods and supplements more than 3 days a week, those possibly have improving effect of defecation and/or loose stool. (3) Subjects who eat food products containing relatively large amount of yogurt, lactic bacteria beverages and dietary fiber more than 3 days a week. (4) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. (5)Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ) containing history of surgical operations. (6)Subjects who excessive alcohol intake. (7)Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work. (8)Subjects who have previous medical history of drug and/or food allergy (especially to milk and/or to shellfish). (9) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. (10)Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. (11) Subjects who donated over 400mL blood and/or blood components within the last three month to the current study. (12) Females who donated over 400mL blood and/or blood components within the last four month to the current study. (13) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (14) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (15)Others who have been determined ineligible by principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intestine regulating function (Gastrointestinal Symptom Rating Scale, stool frequency, stool days, Bristol Stool Form Scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| Defecation status (volume of stool, stool color, odor of stool, refresh feeling of defecation), SF-36 version-2 Incidence rate of side effects and adverse events | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Sales & Planning Department
Outcome results
None listed