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Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia

Primary Purpose

Hyperglycemia

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

About this trial

This is an interventional prevention trial for Hyperglycemia focused on measuring Hydrolysed red ginseng extract, Glucose, Clinical Trial

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 19-80 years with fasting glucose 100-140 mg/dL

Exclusion Criteria:

  • Weight less than 48 kg or weight decreased by more than 10% within past 3 months
  • Have clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, hepatic biliary system, kidney and Urinary system, neuropsychiatry, musculoskeletal, inflammatory and hematologic malignancies, gastrointestinal disorders, etc.
  • Hypoglycemic agent, Obesity medicine, Lipid lowering agent within past 3 months
  • Blood sugar improvement or healthy functional food within past 1 month
  • Under antipsychotic medication therapy within past 2 months
  • History of alcohol or substance abuse
  • Participation in any other clinical trials within past 2 months

  • Laboratory test by show the following results

    • aspartate aminotransferase, alanine aminotransferase > Reference range 3 times upper limit
    • Serum Creatinine > 2.0 mg/dl
  • Pregnancy or breast feeding
  • If a woman of childbearing doesn't accept the implementation of appropriate contraception
  • 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 HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hydrolysed red ginseng extract

Placebo

Arm Description

Hydrolysed red ginseng extract 2.4g/day for 12 weeks

Placebo for 12 weeks

Outcomes

Primary Outcome Measures

Changes of blood glucose
Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention.

Secondary Outcome Measures

Changes of blood insulin
Changes of blood insulin during OGTT were assessed before and after the intervention.
Changes of area under the curve of Glucose and Insulin
Changes of area under the curve of Glucose and Insulin were assessed before and after the intervention.
Changes of Homeostatic model assessment-insulin resistance
Changes of physiological parameter{Homeostatic model assessment-insulin resistance(mg/dl)} were assessed before and after the intervention.
Changes of Homeostatic model assessment-beta-cell
Changes of physiological parameter{Homeostatic model assessment-beta-cell(mg/dl)} were assessed before and after the intervention
Changes of HbA1c
Changes of HbA1c(%) were assessed before and after the intervention
Changes of C-peptide
Changes of C-peptide(ng/ml) were assessed before and after the intervention.
Changes of lipid profile
Changes of lipid profile were assessed before and after the intervention.

Full Information

First Posted
December 12, 2018
Last Updated
May 7, 2020
Sponsor
Chonbuk National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03775733
Brief Title
Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia
Official Title
A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate The Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 7, 2018 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

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 hydrolysed red ginseng extract on improvement of Hyperglycemia.
Detailed Description
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Hydrolysed Red Ginseng extract or a placebo group. Fasting and postprandial glucose profiles during oral glucose tolerance test (OGTT) were assessed before and after the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia
Keywords
Hydrolysed red ginseng extract, Glucose, Clinical Trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hydrolysed red ginseng extract
Arm Type
Experimental
Arm Description
Hydrolysed red ginseng extract 2.4g/day for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Hydrolysed Red Ginseng Extract
Intervention Description
Hydrolysed Red Ginseng Extract 2.4g/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 blood glucose
Description
Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes of blood insulin
Description
Changes of blood insulin during OGTT were assessed before and after the intervention.
Time Frame
12 weeks
Title
Changes of area under the curve of Glucose and Insulin
Description
Changes of area under the curve of Glucose and Insulin were assessed before and after the intervention.
Time Frame
12 weeks
Title
Changes of Homeostatic model assessment-insulin resistance
Description
Changes of physiological parameter{Homeostatic model assessment-insulin resistance(mg/dl)} were assessed before and after the intervention.
Time Frame
12 weeks
Title
Changes of Homeostatic model assessment-beta-cell
Description
Changes of physiological parameter{Homeostatic model assessment-beta-cell(mg/dl)} were assessed before and after the intervention
Time Frame
12 weeks
Title
Changes of HbA1c
Description
Changes of HbA1c(%) were assessed before and after the intervention
Time Frame
12 weeks
Title
Changes of C-peptide
Description
Changes of C-peptide(ng/ml) were assessed before and after the intervention.
Time Frame
12 weeks
Title
Changes of lipid profile
Description
Changes of lipid profile were assessed before and after the intervention.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 19-80 years with fasting glucose 100-140 mg/dL Exclusion Criteria: Weight less than 48 kg or weight decreased by more than 10% within past 3 months Have clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, hepatic biliary system, kidney and Urinary system, neuropsychiatry, musculoskeletal, inflammatory and hematologic malignancies, gastrointestinal disorders, etc. Hypoglycemic agent, Obesity medicine, Lipid lowering agent within past 3 months Blood sugar improvement or healthy functional food within past 1 month Under antipsychotic medication therapy within past 2 months History of alcohol or substance abuse Participation in any other clinical trials within past 2 months Laboratory test by show the following results aspartate aminotransferase, alanine aminotransferase > Reference range 3 times upper limit Serum Creatinine > 2.0 mg/dl Pregnancy or breast feeding If a woman of childbearing doesn't accept the implementation of appropriate contraception 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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo-Wan Chae, MD., PhD
Phone
82-63-259-3040
Email
swchae@jbctc.org

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia

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