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

May 7, 2020 updated by: Soo-Wan Chae, Chonbuk National University Hospital

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

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

Study Overview

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
        • Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group A

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)
Placebo for 12 weeks.
Red Ginseng Concentrated Powder(4.9 g/day) for 12 weeks.
Experimental: group B

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)
Placebo for 12 weeks.
Red Ginseng Concentrated Powder(4.9 g/day) for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of Fasting triglyceride
Time Frame: 12 weeks
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
Time Frame: 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)
30 weeks
Changes of Arteriosclerosis indices
Time Frame: 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

30 weeks
Changes of Carnitine (Serum)
Time Frame: 30 weeks
Carnitine (Serum)[μmol/L] was assessed before and after the intervention.
30 weeks
Changes of lipoprotein lipase
Time Frame: 30 weeks
lipoprotein lipase[ng/ml] was assessed before and after the intervention
30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

May 11, 2018

Study Completion (Actual)

May 8, 2019

Study Registration Dates

First Submitted

January 30, 2019

First Submitted That Met QC Criteria

January 31, 2019

First Posted (Actual)

February 4, 2019

Study Record Updates

Last Update Posted (Actual)

May 8, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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