Healthy volunteers
Conditions
Interventions
Intake of test food for 12 weeks
Intake of placebo for 12 weeks
Sponsors
Soiken Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females whose age of 20 years or more and less than 65 years 2) Subjects whose serum LDL cholesterol levels are 120 mg/dL or more and less than 140 mg/dL (borderline) or 140 mg/dL or more and less than 160 mg/dL (mild Hypercholesterolemia) at the screening examination 3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Exclusion criteria
Exclusion criteria: 1) Subjects receiving a medical treatment for dyslipidemia 2) Subjects receiving a medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 3) Subjects who have the possibility of developing allergic symptoms by the test food 4) Subjects who take Foods for Specified Health Uses or Foods with Function Claims labeled the effects of reducing LDL cholesterol or total cholesterol levels 5) Subjects who take foods having the effects of reducing LDL cholesterol or total cholesterol levels 6) Female subjects who are pregnant or lactating, or intending to become pregnant during the study 7) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood) 8) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 9) Subjects deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL cholesterol | — |
Secondary
| Measure | Time frame |
|---|---|
| HDL cholesterol, Total cholesterol, non-HDL cholesterol, Triglycerides | — |
Countries
Japan
Contacts
Public ContactTomohiro Sugino
Soiken Inc. R&D Division
Outcome results
None listed