healthy person
Conditions
Interventions
Secoisolariciresinol diglucoside (SDG) 60mg (2 capsules once a day)
Placebo food (2 capsules once a day)
Sponsors
Clinical Creative Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females between the ages of 20-65 years at the time of consent. 2) Those who are able to consume the test meal continuously. 3) Those whose blood LDL cholesterol level is between 120 mg/dl and 140 mg/dl. 4) Those with a blood HDL cholesterol level of 40 mg/dl or higher. 5) Those who are concerned about maintaining the health of their blood vessels. 6) Those who can avoid binge drinking and excessive exercise during the study period and lead the same lifestyle (diet, exercise, etc.) as before the study period. 7) Those who have received sufficient explanation of the purpose and content of this study, have the ability to consent, and can voluntarily volunteer to participate with a good understanding of the study, and agree to participate in this study in writing.
Exclusion criteria
Exclusion criteria: 1) Those who show allergic reactions to flaxseed. 2) Those who are in the habit of consuming large amounts of flaxseed and the Study Food Ingredients (SDG). 3) Those who are pregnant or intend to become pregnant during the study period, or those who are lactating. 4) Those who have participated in other clinical studies within 3 months of consent and those who plan to participate in other clinical studies during the study period. 5) Subjects whose anthropometric, physical, or clinical values in the preliminary examination are significantly out of the reference range. 6) Those who regularly use medicines, food for specified health use, functional food, or health food that may affect the evaluation items. 7) Those who have a history of drug dependence or alcohol dependence, or a current medical history. 8) Those who are undergoing treatment for a disease, or have a history of a serious disease that required medication. 9) Patients with serious diseases such as diabetes, hepatic disease, renal disease, or cardiac disease, or those with a history of such diseases. 10) Others who are judged by the principal investigator or sub-investigator to be inappropriate for the study (the study may increase the risk to the research subjects or may not provide sufficient data).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Low-density lipoprotein cholesterol | — |
Secondary
| Measure | Time frame |
|---|---|
| Total cholesterol High-density lipoprotein cholesterol LDL/HDL ratio Liver function markers in blood (Aspartate transaminase,Alanine aminotransferase,Gamma-glutamyl transpeptidase) Triglyceride Systolic blood pressure, diastolic blood pressure Heart rate | — |
Countries
Japan
Contacts
Public ContactKazuhiro Ohno
Clinical Creative Co., Ltd. Pharmaceutical Development Division
Outcome results
None listed