Healthy adults
Conditions
Interventions
Oral intake of the test foods containing plant extract for 12 weeks
Sponsors
Nippn Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese Men and women between the ages of 20 and 64 at the time of obtaining informed consent 2) Healthy adults
Exclusion criteria
Exclusion criteria: 1) Participants currently undergoing treatment, taking medication, or visiting a hospital for any disease. 2) Participants who are pregnant, breastfeeding, or who may become pregnant during the study period. 3) Participants who have an alcohol dependence. 4) Participants who are allergic to ingredients related to the test food. 5) Participants who are participating in other clinical studies. 6) Participants who have a history of serious hepatic or kidney damage, heart disorders. 7) Participants with a history of or current hepatitis. 8) Participants with severe anemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, physical measurement (body weight and body mass index), physical examination (blood pressure, heart rate, body temperature), and laboratory tests (hematology test, blood biochemistry test, urine test), Doctor's interview (Pre-intake, 2 weeks, 4 weeks, 8weeks and 12 weeks after intake, and 2 weeks after the end of intake of test food) | — |
Countries
Japan
Contacts
Public ContactKou Masuda
SOUKEN Co., Ltd. Secretariat
Outcome results
None listed