Hyperlipidemias
Conditions
Keywords
Red Ginseng Concentrated Powder, Hyperlipidemias, Clinical Trial
Brief summary
This study was conducted to investigate the effects of daily supplementation of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level.
Detailed description
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.)
Interventions
DIETARY_SUPPLEMENTRed Ginseng Concentrated Powder
Red Ginseng Concentrated Powder(4.9 g/day) for 12 weeks.
DIETARY_SUPPLEMENTPlacebo
Placebo for 12 weeks.
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Fasting triglyceride | 12 weeks | Changes of Fasting triglyceride was assessed before and after the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Lipid metabolism indices | 30 weeks | 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) |
| Changes of Arteriosclerosis indices | 30 weeks | 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 |
| Changes of Carnitine (Serum) | 30 weeks | Carnitine (Serum)\[μmol/L\] was assessed before and after the intervention. |
| Changes of lipoprotein lipase | 30 weeks | lipoprotein lipase\[ng/ml\] was assessed before and after the intervention |
Countries
South Korea
Outcome results
None listed