Mild abnormality of lipid metabolism
Conditions
Interventions
Sponsors
Department of Obstetrics and Gynecology, Nasu Red Cross Hospital
Innovation Division, Kagome Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Postmenopausal women whom meeting the following requirements will be included. Postmenopausal women show at least one the below values of three biomarkers of blood lipids; TC: 200 mg/dL or more LDL-C: 120 mg/dL or more HDL-C: less than 40 mg/dL (Who gave the informed consents in writing after receiving enough explanation of the purpose and detail of the study, understanding the study well, and deciding to attend the study with their own will.)
Exclusion criteria
Exclusion criteria: We will exclude outpatients 1) who show the abnormal value of blood lipids (TC:260 mg/dL or more, LDL-C:180 mg/dL or more, HDL-C: less than 30 mg/dL), and then are or will be undergoing treatment for abnormal lipid metabolism 2) who regularly use hormone preparations and hypolipidemic drug, and then are judged unsuitable for this study 3) with serious liver diseases in their life or suspected liver diseases 4) with serious diseases in their life and then judged unsuitable for this study 5) with serious diseases such as heart diseases, kidney diseases, organ damage and diabetes 6) with risk of allergy 7) who habitually consume higher amount of alcohol (> avg 60 g alcohol/day) 8) who participated in other clinical trials within 2 months 9) who are judged unsuitable for this study by principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biomarkers of blood lipids such as TC, LDL-C and HDL-C will be measured as primary endpoint. The changes will be compared within each group and between the treatment groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary endpoints, following items will be evaluated; physical parameters, blood biochemical values, biomarkers of oxidative stress and inflammation, variety and ratio of bacteria in stool (intestinal microbiota) | — |
Countries
Japan
Contacts
Public ContactKuniaki Ota
Nasu Red Cross Hospital Department of Obstetrics and Gynecology
Outcome results
None listed