Study for evaluating the safety of excessive intake of food containing plant-derived constituent
- Conditions
- one (Healthy adults)
- Registration Number
- JPRN-UMIN000033873
- Lead Sponsor
- KSO Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method