Efficacy and Safety Morus Alba L. Extract on Improvement of Blood Flow

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety Morus Alba L. Extract on Improvement of Blood Flow

Conditions
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Blood Flow

Intervention / Treatment
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* Dietary Supplement: Morus Alba L. Extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Those with a fasting total cholesterol of 200 239 mg/dL Those with a fasting LDL-cholesterol of 130 159 mg/dL Those with a fasting blood sugar of 100 125 mg/dL Those with a SBP of 120 139 mmHg Those with a BMI of 25 29.9 kg/m^2 Waist Hip Ratio (WHR) is 0.9 or more for males and 0.85 or more for females Exclusion Criteria: Those with platelet aggregation and significant disability The platelet count is less than 100,000/μL or more than 500,000/μL The Hematocrit is less than 25% 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 AST, ALT > Reference range 3 times upper limit Serum Creatinine > 2.0 mg/dL 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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Morus Alba L. extract<br>Morus Alba L. extract 30 ml/day for 12 weeks | Dietary Supplement: Morus Alba L. Extract<br>* Morus Alba L. Extract 30 ml/day for 12 weeks.<br>|
| Placebo Comparator: Placebo<br>Placebo 30 ml/day for 12 weeks | Dietary Supplement: Placebo<br>* Placebo 30 ml/day for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morus Alba L. Extract, Clinical Trial