None (Healthy adults)
Conditions
Interventions
Food containing plant-derived constituent, 12 portion of food per day for 4 weeks.
Placebo food, 12 portion of food per day for 4 weeks.
Sponsors
KSO Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Healthy males and females aged from 20 to less than 65 years old when giving the informed consent. (2)Subjects with BMI from 18.5 to less than 30 kg/m2 at the screening. (3)Subjects giving the informed consents in writing after receiving explanation of the purpose and details of the study, understanding the study and deciding to attend the study with their own will.
Exclusion criteria
Exclusion criteria: (1)Subjects on a diet. (2)Subjects using medication affecting lipid metabolism. (3)Subjects constantly using supplements or functional foods affecting lipid metabolism (including foods for specified health uses and foods with function claims). (4)Subjects using foods containing ingredients of test food constantly. (5)Subjects with excessive alcohol-drinking behaviors (maximum daily quantity: approximately 20 g of pure alcohol per day). (6)Subjects who cannot stop drinking for two days until the screening and each checkup. (7)Subjects with food allergy. (8)Subjects with serious diseases (e.g., diabetes, kidney disease, liver disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorders. (9)Subjects with chronic diseases and using medicines continuously. (10)Subjects having a medical history of diseases affecting digestion and absorption. (11)Subjects with implantable medical devices (e.g., cardiac pace maker and implantable defibrillator) (12)Subjects judged unsuitable for the study based on the results of blood test. (13)Subjects with anemia. (14)Subjects having donated over 200 mL of blood or blood component within the last one month prior to the current study or over 400 mL of blood or blood component within the last three months prior to the current study. (15)Subjects diagnosed with familial hyperlipidemia. (16)Subjects under treatment or a history of drug addiction and/or alcoholism. (17)Subjects participating or willing to participate in other clinical studies with the intake of food or pharmaceutical products, or with the swab of cosmetic or pharmaceutical products. (18)Subjects who are pregnant, breastfeeding, or planning to be pregnant in the near future. (19)Subjects working for a company developing or manufacturing functional foods. (20)Subjects judged unsuitable for this study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Interview by physician 2. Height and body weight 3. Blood pressure and pulse 4. Hematological test 5. Biochemical test 6. Urine analysis 7. Subjective symptom and objective response 8. Adverse events | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Sales Department
Outcome results
None listed