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Completed

NCT Number: NCT03828188

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.

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Key information

Conditions

Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

About this study

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.)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Red Ginseng Concentrated Powder

Dietary Supplement

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

Placebo

Dietary Supplement

Placebo for 12 weeks.

Primary outcomes

  1. Changes of Fasting triglyceride

    Time frame: 12 weeks

    Changes of Fasting triglyceride was assessed before and after the intervention

Secondary outcomes

  1. 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)

  2. 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

  3. Changes of Carnitine (Serum)

    Time frame: 30 weeks

    Carnitine (Serum)[μmol/L] was assessed before and after the intervention.

  4. Changes of lipoprotein lipase

    Time frame: 30 weeks

    lipoprotein lipase[ng/ml] was assessed before and after the intervention

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Feb 4, 2019
Registry last updated
May 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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