Healthy adults
Conditions
Interventions
Ingestion of placebo beverage for 12 weeks.
Ingestion of beverage containing plant-derived components for 12 weeks.
Sponsors
KAGOME CO., LTD.
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy adults over 20 years old and under 65 years old.between 20 and 65 years old. 2. Subjects whose LDL-cholesterol less than 139 mg/dL based on Friedewald's equation in the pre-test. 3. Subjects who fully understand the purpose and content of the study and agree to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Subjects with dyslipidemia or familial hypercholesterolemia. 2. Subjects who have a disease under treatment or have a history of serious disease (dyslipidemia, diabetes, liver disease, renal disease, cardiac disease, psychiatric disease, etc.) that required medication treatment. 3. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc . 4. Subjects those who use health foods that may affect lifestyle-related diseases (blood lipid, blood pressure, blood glucose, uric acid levels). 5. Subjects who have had allergic reactions to drugs or foods especially test food. 6. Subjects who regularly take foods containing a large amount of plant-derived component. 7. Subjects who smoke excessive amounts of cigarettes on a daily basis (21 cigarettes/day or more). 8. Subjects who drink excessive amounts of alcohol on a daily basis (more than 20 g/day of pure alcohol equivalent three times or more per week). 9. Subjects who have an exercise habit (3 times a week or more) . 10. Subjects who are judged to be unsuitable for the study based on their responses to the screening questionnaire. 11. Subjects whose physical measurements, physical examination values, and clinical laboratory values on the pre-test are significantly out of the reference range. 12. Subjects who are participating in other clinical studies at the time this study is initiated. 13. Women who expected to be pregnant or lactating during this study. 14. Subjects who have irregular lifestyle such as shift workers, late night workers, etc. 15. Subjects who are judged unsuitable for this study by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL-cholesterol at 12 weeks of ingestion. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in LDL-cholesterol at 12 weeks of ingestion. 2) Concentration of serum plant-derived component at 12 weeks of ingestion. 3) Change in concentration of serum plant-derived component at 12 weeks of ingestion. | — |
Countries
Japan
Contacts
Public ContactKeiji Yamamoto
EP Mediate Co., Ltd. Foods Department, Trial Planning Section 1
Outcome results
None listed