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

Primary Purpose

Hyperlipidemias

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Red Ginseng Concentrated Powder
Placebo
Sponsored by
Chonbuk National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperlipidemias focused on measuring Red Ginseng Concentrated Powder, Hyperlipidemias, Clinical Trial

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

group A

group B

Arm Description

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 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)

Outcomes

Primary Outcome Measures

Changes of Fasting triglyceride
Changes of Fasting triglyceride was assessed before and after the intervention

Secondary Outcome Measures

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

Full Information

First Posted
January 30, 2019
Last Updated
May 7, 2020
Sponsor
Chonbuk National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03828188
Brief Title
Efficacy and Safety of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
May 11, 2018 (Actual)
Study Completion Date
May 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias
Keywords
Red Ginseng Concentrated Powder, Hyperlipidemias, Clinical Trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Experimental
Arm Description
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)
Arm Title
group B
Arm Type
Experimental
Arm Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Red Ginseng Concentrated Powder
Intervention Description
Red Ginseng Concentrated Powder(4.9 g/day) for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo for 12 weeks.
Primary Outcome Measure Information:
Title
Changes of Fasting triglyceride
Description
Changes of Fasting triglyceride was assessed before and after the intervention
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes of Lipid metabolism indices
Description
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)
Time Frame
30 weeks
Title
Changes of Arteriosclerosis indices
Description
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
Time Frame
30 weeks
Title
Changes of Carnitine (Serum)
Description
Carnitine (Serum)[μmol/L] was assessed before and after the intervention.
Time Frame
30 weeks
Title
Changes of lipoprotein lipase
Description
lipoprotein lipase[ng/ml] was assessed before and after the intervention
Time Frame
30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
54907
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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