Healthy adults
Conditions
Interventions
Ingestion of the test beverage (3 bottles/day) to the subjects for 4 weeks.
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy male/female subjects ranging in age from 20 to 59 (including four subjects with some constipation tendency). (2) Subjects who give informed consent to participate in this clinical trial after being provided with an explanation of our experimental protocol detail.
Exclusion criteria
Exclusion criteria: (1) Subjects with some kind of continuous medical treatment. (2) Subjects with current and/or previous medical history of serious diseases in heart, liver, kidney and/or digestive organs. (3) Subjects who have constantly used the following foods that might affect their blood glucose level, triglyceride level, and intestine-regulating function; health-specific, functional, health foods. (4) Subjects with excessive alcohol intake. (5) Subjects with extremely irregular dietary habits and/or life rhythm. (6) Pregnant or possibly pregnant women, or lactating ones. (7) Subjects with drug and/or food allergy (especially in milk and soybean). (8) Subjects with weak stomach and/or diarrhea-prone constitution. (9) Subjects who are now under the other clinical tests with some kind of medicine/food, or participated those tests within four weeks after this clinical trial. (10) Subjects who donated over 200 mL of their blood and/or blood components within a month to this clinical trial. (11) Males who donated their whole blood (400 mL) within the last three months to this trial. (12) Females who donated their whole blood (400 mL) within the last four months to this trial. (13) Males who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial. (14) Females who will be collected in total of their blood (800 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial. (15) Others who have been determined as ineligible for participation in this trial, according to the principal/sub investigator's opinions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rates of some kind of adverse event and/or side effect | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Physical measurement 2. Physiological test 3. Hematological test 4. Blood-biochemical test 5. General urinalysis | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Planning & Sales Department
Outcome results
None listed