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

• Sponsor: Chonbuk National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03828188
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.2
• Patients Per Site Per Month: 3.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperlipidemias	Dietary Supplement: Red Ginseng Concentrated Powder; Dietary Supplement: Placebo	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Mar 1, 2018
• Actual Primary Completion Date: May 11, 2018
• Actual Study Completion Date: May 8, 2019

Arms and Interventions

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)	Dietary Supplement: Red Ginseng Concentrated Powder; Red Ginseng Concentrated Powder(4.9 g/day) for 12 weeks.; Dietary Supplement: Placebo; Placebo 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)	Dietary Supplement: Red Ginseng Concentrated Powder; Red Ginseng Concentrated Powder(4.9 g/day) for 12 weeks.; Dietary Supplement: Placebo; Placebo for 12 weeks.

Outcome Measures

Primary Outcome Measures

1. Changes of Fasting triglyceride [12 weeks]

   Changes of Fasting triglyceride was assessed before and after the intervention

Secondary Outcome Measures

1. 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)

2. 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

3. Changes of Carnitine (Serum) [30 weeks]

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

4. Changes of lipoprotein lipase [30 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Trial Center for Functional Foods Chonbuk National University Hospital	Jeonju	Jeollabuk-do	Korea, Republic of	54907

Sponsors and Collaborators

• Chonbuk National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
• ClinicalTrials.gov Identifier: NCT03828188
• Other Study ID Numbers: JAR-FHL-RG2
• First Posted: Feb 4, 2019
• Last Update Posted: May 8, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital: Red Ginseng Concentrated Powder; Hyperlipidemias; Clinical Trial
• Additional relevant MeSH terms: Hyperlipidemias; Hyperlipoproteinemias

Study Results

No Results Posted as of May 8, 2020