Efficacy and Safety of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level

Study Overview
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Brief Summary
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This study was conducted to investigate the effects of daily supplementation of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level.

Detailed Description
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This study was a 12-week, randomized, double-blind, placebo-controlled 2x2 cross-over design human trial. 50 subjects which of 25 by group were randomly divided into Red Ginseng Concentrated Powder and a placebo group.(A total of 100 subjects completed the 2x2 cross-over study.)

Official Title
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A 12-week, Randomized, Double-blind, Placebo-controlled 2x2 Cross-over Design Human Trial to Evaluate the Efficacy and Safety of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level

Conditions
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Hyperlipidemias

Intervention / Treatment
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* Dietary Supplement: Red Ginseng Concentrated Powder
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19-70 years with Triglyceride 120-200 mg/dL Exclusion Criteria: Lipid lowering agent within past 6 months Those with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders Persons with significant hypersensitivity reactions to ginseng and red ginseng Those with a history of gastrointestinal disorders (ex, Crohn's disease) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of a product for clinical trials Those who have received antipsychotic medication within 2 months before screening Those with a history of alcoholism or substance abuse Those who participated in other clinical trials within 2 months before screening Laboratory test by show the following results Aspartate Transaminase(AST), Alanine Transaminase(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: 19 Years
Maximum Age: 70 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>Red Ginseng Concentrated Powder in 12 weeks → rest in 4 weeks → Placebo 12 weeks. Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day) Placebo: Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day) | Dietary Supplement: Red Ginseng Concentrated Powder<br>* Red Ginseng Concentrated Powder(4.9 g/day) for 12 weeks.<br>Dietary Supplement: Placebo<br>* Placebo for 12 weeks.<br>|
| Experimental: group B<br>Placebo 12 weeks→ rest in 4 weeks → Red Ginseng Concentrated Powder in 12 weeks. Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day) Placebo: Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day) | Dietary Supplement: Red Ginseng Concentrated Powder<br>* Red Ginseng Concentrated Powder(4.9 g/day) 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 Fasting triglyceride | Changes of Fasting triglyceride was assessed before and after the intervention | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Lipid metabolism indices | Lipid metabolism indices were assessed before and after the intervention. The lipid metabolism index should be measured by collecting blood while keeping fasting for 12 hours or more. The inspection items are as follows. Total cholesterol, triglyceride, LDL-C, HDL-C, Non HDL-C, VLDL-C, free fatty acid, Apo A1, Apo B, hs-CRP Non HDL-C and VLDL-C are calculated by the calculation formula, and the first digit of the decimal point is indicated. Non HDL-C= Total cholesterol - HDL-C VLDL-C= Total cholesterol - (HDL-C + LDL-C) | 30 weeks | 
| Changes of Arteriosclerosis indices | It is calculated by the calculation formula using the lipid metabolism indicator test item. Round off the third decimal place to the second decimal place. The items are as follows: * Total cholesterol/HDL-C, LDL-C/HDL-C, triglycerid/HDL-C, (Total cholesterol - HDL-C)/HDL-C, Apo B/Apo A1 | 30 weeks | 
| Changes of Carnitine (Serum) | Carnitine (Serum)[μmol/L] was assessed before and after the intervention. | 30 weeks | 
| Changes of lipoprotein lipase | lipoprotein lipase[ng/ml] was assessed before and after the intervention | 30 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Red Ginseng Concentrated Powder, Hyperlipidemias, Clinical Trial