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The effect of 12 weeks intake of Morus alba L. on blood circulation improvement and related indicators is assessed compared to placebo intake.
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Hundred subjects were randomly divided into Morus alba L. extract or a placebo group. Blood was collected and changes in blood circulation related indicators were observed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morus Alba L. extract | Experimental | Morus Alba L. extract 30 ml/day for 12 weeks |
|
| Placebo | Placebo Comparator | Placebo 30 ml/day for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morus Alba L. Extract | Dietary Supplement | Morus Alba L. Extract 30 ml/day for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Reactive Hyperemia Index | Reactive Hyperemia Index was measured in study visit 1(0 week) and visit 3(12 weeks). | 12 weeks |
| Changes of Platelet function assay | The whole blood with anticoagulant (sodium citrate) is passed through the capillary and the membrane to assess the degree of platelet adhesion to this membrane and the degree of occlusion of the capillary. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of blood flow indices: PAI-1, t-PA | Blood flow indices(PAI-1, t-PA) were measured in study visit 1(0 week) and visit 3(12 weeks). | 12 weeks |
| Changes of Pulse wave | Measured using a pulse wave measuring device (uBioClipTM; BiosenseCreative Co., Ltd., Seoul, Korea) and measured three times, the average value of the measured values is indicated. |
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Inclusion Criteria:
Exclusion Criteria:
Those with platelet aggregation and significant disability
BMI is less than 18.5kg/m^2 or greater than 30kg/m^2
Those with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
Those with a history of clinically significant hypersensitivity to mulberry
Those who have been taking platelet function, blood circulation improvement and hyperlipidemia related medicines, health functional food or herbal medicine continuously for more than 7 days within one month before screening
Those who have received antipsychotic medication within 2 months before screening
Those who participated in other clinical trials within 3 months before screening
Women receiving hormone replacement therapy
Laboratory test by show the following results
Pregnancy or breast feeding
Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soo Wan Chae, Ph.D., M.D. | Contact | 82-63-259-3040 | soowan@jbnu.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center for Functional Foods Chonbuk National University Hospital | Recruiting | Jeonju | Jeollabuk-do | 54907 | South Korea |
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| Placebo | Dietary Supplement | Placebo 30 ml/day for 12 weeks. |
|
| 12 weeks |
| Changes of Oxidation stress index: Oxidized LDL | Oxidation stress indices(Oxidized LDL) was measured in study visit 1(0 week) and visit 3(12 weeks). | 12 weeks |
| Changes of Lipid peroxidation index: MDA (Malondialdehyde) | Lipid peroxidation index{MDA(Malondialdehyde)} was measured in study visit 1(0 week) and visit 3(12 weeks). | 12 weeks |
| Changes of Lipid metabolism indices: Total cholesterol, Triglyceride, LDL-C, HDL-C | Lipid metabolism indices(Total cholesterol, Triglyceride, LDL-C, HDL-C) were measured in study screening and visit 3(12 weeks). | 12 weeks |
| Changes of Arteriosclerosis indices: Total cholesterol/HDL-C, LDL-C/HDL-C, Triglyceride/HDL-C, (Total cholesterol-HDL-C)/HDL-C | It is calculated by the calculation formula using the lipid metabolism indicator test item. | 12 weeks |