Healthy adult
Conditions
Interventions
Intake of test food, for 12 weeks
Intake of placebo, for 12 weeks
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females aged 20 to 64 years at the time of obtaining consent 2) Subjects with LDL cholesterol levels below 140 mg/dL at screening, as calculated by the Friedewald formula 3) Subjects who fully understand the purpose and details of the study and voluntarily consent to participate
Exclusion criteria
Exclusion criteria: 1) Subjects who currently have any medical condition under treatment, or who have a history of serious illnesses requiring pharmacological treatment 2) Subjects who are considered to have dyslipidemia or familial hypercholesterolemia 3) Subjects with food allergies or potential allergy risk to the test food 4) Subjects habitually using substances that may influence lipid metabolism, including drugs, FOSHU, functional foods, supplements, or health products 5) Subjects who habitually consume FOSHU, functional foods, or supplements and are unable to discontinue them during the study 6) Subjects with irregular lifestyles, such as shift or night workers 7) Subjects who drink daily and consume more than 20 g of pure alcohol per day 8) Subjects who smoke more than 20 cigarettes per day 9) Subjects unable to consume the test food as instructed 10) Subjects who use implantable medical electrical devices, such as pacemakers 11) Subjects who use implantable metallic medical devices 12) Subjects unable to maintain their pre-study lifestyle habits during the study period 13) Subjects unable to avoid significant deviations from their pre-study lifestyle during the study 14) Subjects who plan to become pregnant or breastfeed during the study 15) Subjects who have participated in other clinical studies within 3 months prior to the start of this study, are currently participating, or wish to participate in such studies during the study 16) Subjects with significantly abnormal values deviating from the reference range in physical measurements, physical examinations, or clinical laboratory tests prior to intake 17) Subjects who are judged to be unsuitable based on their responses to the background survey 18) Subjects who are judged unsuitable for the study by the principal investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood lipids | — |
Secondary
| Measure | Time frame |
|---|---|
| Biochemical tests and physical examinations related to blood lipids | — |
Countries
Japan
Contacts
Public ContactHiroyasu Shimada
EP Mediate Co., Ltd. Development Department Trial Planning Section
Outcome results
None listed