None (Healthy adults)
Conditions
Interventions
Intake period: 12 weeks Test food: Hard capsules containing 800 mg vegetable sterol formulation (phytosterols content 400 mg/6 capsules ) Twice a day (6 capsules/day)
Intake period: 12 weeks Te
Sponsors
Riken Vitamin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese males and females between the ages of 20 and 65 years at the time of consent. 2. Participants with borderline high LDL cholesterol (120 mg/dL or more and less than 140 mg/dL). 3. Participants who have been fully informed of the purpose and content of this study and who have signed an informed consent form prior to the start of this study.
Exclusion criteria
Exclusion criteria: 1. Those who are currently being treated for a serious illness. 2. Sitosterolemia. 3. Participants with food allergies or who may have an allergic reaction to the test food. 4. Those who regularly consume medicines or quasi-drugs that may affect the test items. 5. Those who regularly consume health foods (foods for specified health uses, foods with nutrient function claims, foods with functional claims, dietary supplements, etc.) that may affect the test items. 6. Those who are unable to discontinue the use of drugs(except for medication as needed), quasi-drugs, or health foods (foods for specified health uses, foods with nutrient function claims, foods with functional claims, dietary supplements, etc.) from the time of obtaining consent to the end of this study. 7. Those who work day and night shifts and those who plan to work multiple night shifts during this study. 8. Those whose normal alcohol consumption exceeds 20 g of alcohol equivalent per day. 9. Those whose normal smoking amount exceeds 20 cigarettes per day. 10.Those participating in other studies or who have participated in other studies within the past 3 months. 11.Those who intends to participate in other clinical studies during this study period. 12.Those who are unable to maintain their daily lifestyle (diet, exercise, smoking etc.). 13.Those who have difficulty consuming the test food as instructed. 14.Pregnant, lactating, or wishing to become pregnant. 15.Those determined by the principal investigator to be inappropriate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL cholesterol: 12 weeks after the start of intake | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy LDL Cholesterol: baseline, 4 and 8 weeks after the start of intake HDL cholesterol, non-HDL cholesterol, total cholesterol, LDL/HDL ratio, triglyceride: baseline, 4, 8, and 12 weeks after the start of intake Safety Incidence of side effects and adverse events: 12 weeks after the start of intake Physical examination, hematological examination, blood biochemistry test, urinalysis: baseline, 4, 8, and 12 weeks after the start of intake | — |
Countries
Japan
Contacts
Public ContactRyuto Takahashi
Riken Vitamin Co., Ltd. Healthcare Unit
Outcome results
None listed