Efficacy and Safety of Unripe Bokbunja Extract on Improvement of Blood Cholesterol

Study Overview
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Brief Summary
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This study was conducted to investigate the effects of daily supplementation of unripe Bokbunja extract on improvement of blood cholesterol.

Detailed Description
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This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Forty subjects were randomly divided into unripe Bokbunja extract 600 mg or placebo group. The investigators measured total cholesterol, lipid profile, arteriosclerosis index, anthropometric index, oxidized LDL.

Official Title
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A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Unripe Bokbunja Extract on Improvement of Blood Cholesterol

Conditions
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Blood Cholesterol

Intervention / Treatment
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* Dietary Supplement: unripe Bokbunja Extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 20 and 65 years, Total cholesterol 200-239 mg/dl subjects giving written informed consent Exclusion Criteria: Cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease or gastrointestinal surgery Participation in any other clinical trials within past 2 months Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study Pregnancy or breast feeding etc,.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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: unripe Bokbunja Extract<br>tablet(1 tablet/d, 600 mg/d) for 12 weeks | Dietary Supplement: unripe Bokbunja Extract<br>* tablet(1 tablet/d, 600 mg/d) for 12 weeks<br>Dietary Supplement: Placebo<br>* Placebo for 12 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo for 12 weeks | Dietary Supplement: unripe Bokbunja Extract<br>* tablet(1 tablet/d, 600 mg/d) for 12 weeks<br>Dietary Supplement: Placebo<br>* Placebo for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Total cholesterol | Changes of total cholesterol were assessed before and after the intervention | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Lipid profile(total cholesterol, LDL-cholesterol, triglyceride, HDL-cholesterol, free fatty acid, Apolipoprotein A1, Apolipoprotein B, Lipoprotein a, hs-CRP) | Changes of lipid profile(total cholesterol, LDL-cholesterol, triglyceride, HDL-cholesterol, free fatty acid, Apolipoprotein A1, Apolipoprotein B, Lipoprotein a, hs-CRP) were assessed before and after the intervention | 12 weeks | 
| Changes of Arteriosclerosis index(total cholesterol/HDL-cholesterol, LDL-cholesterol/HDL-cholesterol, triglyceride/HDL-cholesterol, (total HDL-cholesterol-HDL-cholesterol)/HDL-cholesterol, Apolipoprotein B/Apolipoprotein A1) | Changes of arteriosclerosis index(total cholesterol/HDL-cholesterol, LDL-cholesterol/HDL-cholesterol, triglyceride/HDL-cholesterol, (total HDL-cholesterol-HDL-cholesterol)/HDL-cholesterol, Apolipoprotein B/Apolipoprotein A1) were assessed before and after the intervention | 12 weeks | 
| Changes of Anthropometric index(weight, body mass index, waist hip ratio, waist, hip, fat percentage, lean body mass) | Changes of anthropometric index(weight, body mass index, waist hip ratio, waist, hip, fat percentage, lean body mass) were assessed before and after the intervention | 12 weeks | 
| Changes of Oxidized LDL | Changes of oxidized LDL were assessed before and after the intervention | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholesterol, Bokbunja, Clinical Trial