Healthy male/female adults
Conditions
Interventions
Consumption of the test food (1 drop) to the subjects after breakfast (i.e., once a day).
Consumption of the placebo food (1 drop) to the subjects after breakfast (i.e., once a day).
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy male/female subjects ranging in age from 20 to 64. (2) Subjects having their defecation within 3~5 times a week. (3) Subjects who gave informed consent to participate in this trial after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: (1) Subjects with some kind of medical treatment continuously. (2) Subjects who have used some kind of medicine that might affect their intestine-regulating and immune functions. (3) Subjects who have used the following foods that might affect their intestine-regulating and immune functions; health-specific, functional, supplemental, health foods. (4) All through this trial, subjects who have any difficulty in refraining from having denying/restricting foods. (5) Pregnant or possibly pregnant women, or lactating ones. (6) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. (7) Subjects with excessive alcohol intake. (8) Subjects with extremely irregular life rhythms, and subjects with midnight work or irregular shift work. (9) Subjects with previous medical history of drug and/or food allergy (especially in a soybean). (10) Subjects who are now under the other clinical tests with some kind of medicine/food, or participated those tests within four weeks after the current trial. (11) Subjects who donated over 200 mL of their whole blood and/or blood components within a month to the current trial. (12) Male subjects who donated over 400 mL of their whole blood within the last three months to the current trial. (13) Female subjects who donated over 400 mL of their whole blood within the last four months to the current trial. (14) Male subjects who will be collected over 1200 mL in total of their blood within the last twelve months, after adding the planned sampling blood amounts in this trial. (15) Female subjects who will be collected over 800 mL in total of their blood within the last twelve months, after adding the planned sampling blood amounts in this trial. (16) Others who have been determined as ineligible for participation, according to the principal/sub investigator's opinions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Bowel movement situation (frequency, number of days, amount, nature) 2. CAS-MT | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Amplicon sequence analysis of changes in the behavior of intestinal bacterial flora 2. Bowel movement situation (color, smell, abdominal muscle pressure, feeling of constipation, abdominal pain) 3. NK cell activity 4. Changes in laboratory value | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Planning & Sales Department
Outcome results
None listed