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

Not Applicable

Completed

• Conditions: Hyperlipidemias
• Interventions: Dietary Supplement: Red Ginseng Concentrated Powder; Dietary Supplement: Placebo

• Registration Number: NCT03828188
• Lead Sponsor: Chonbuk National University Hospital

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.)

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2018-05-11
• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-04
• Study Completion: 2019-05-08
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-07
• Last Update Posted: 2020-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
group A	Placebo	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)
group B	Placebo	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)
group A	Red Ginseng Concentrated Powder	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)
group B	Red Ginseng Concentrated Powder	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)

Primary Outcome Measures

Name	Time	Method
Changes of Fasting triglyceride	12 weeks	Changes of Fasting triglyceride was assessed before and after the intervention

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Clinical Trial Center for Functional Foods Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of