hypercholesterolemia
Conditions
Interventions
Food1(Intake priod:12 weeks)
Food2(Intake priod:12 weeks)
Placebo(Intake priod:12 weeks)
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)20 to 75 years at the time of informed consent and possible to visit. 2)Japanese males and females. 3)LDL-Cho >=140 mg/dl and <200 mg/dl.
Exclusion criteria
Exclusion criteria: 1)Subjects who is taking the following medications within 3 months, or who is scheduled to take medication after informed consent to participate in this examination. Fibrate-based medicine (bezafibrate etc), nicotinic acid, azole antifungal drug (itraconazole etc), macrolide antibiotics(erythromycin etc), coumarin-based anticoagulants(warfarin), antacid(magnesium hydroxide, aluminium hydroxide), lopinavir and ritonavir combination drug,Simeprevir, eltrombopag. 2)Subjects using steroidal and non-steroidal medicines (internal medicine / topical medicine). 3)Subjects who regularly use chemicals (orlistat (Xenical, Arai )etc) affecting fat absorption. 4)Subjects who previous or present serious disease such kidney, liver, circulatory system, benign neoplasm,mental, dementing disorder. 5)Subjects who are alcoholics or previous. 6)Subjects with hypothyroidism, patients with hereditary muscle disease (muscular dystrophy etc) or their family history, or those with a history of drug-induced myopathy. 7)Subjects who are receiving medication in diabetic patients or hypertensive patients. 8)Subjects who have allergy related to the study foods. 9)Subjects who using health foods (supplements, foods for specified health use, displayed functional foods), quasi-drugs, medicines that decrease LDL cholesterol. 10)Subjects who are participating within 3 months or planning to participate in other clinical study. 11)Subjects who are pregnant or breast-feeding. 12)Subjects who are judged as unsuitable for the study by the doctor and the investigator in charge for other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood LDL- cholesterol level | — |
Secondary
| Measure | Time frame |
|---|---|
| blood total- cholesterol level blood non-HDL- cholesterol level | — |
Countries
Japan
Contacts
Public ContactMasao Matsuoka
HUMA R&D CORP Clinical Development Division
Outcome results
None listed