Efficacy and Safety of Hydrolyzed Ginseng Extract on Impaired Fasting Glucose

March 13, 2016 updated by: Soo-Wan Chae, Chonbuk National University Hospital

An 8 Weeks, Randomized, Double-blind, Placebo-controlled Clinical Trial for Anti-diabetic Effects of Hydrolyzed Ginseng Extract

This study was conducted to investigate the effects of daily supplementation of hydrolyzed ginseng extract(HGE) on glycemic status in subjects with impaired fasting glucose(IFG).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was a 8 weeks, randomized, double-blind, placebo-controlled trial. Twenty subjects were randomly divided into HGE or a placebo group. Fasting and postprandial glucose profiles during oral glucose tolerance test (OGTT) were assessed before and after the intervention.

Study Type

Interventional

Enrollment (Actual)

20

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

  • Korea, Republic of
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
        • 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

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 20-70 years with fasting glucose 100~126 mg/dL

Exclusion Criteria:

  • Abnormal lipid profile values
  • Acute/chronic inflammation
  • Treated with corticosteroid within past 4 weeks
  • Cardiovascular disease
  • Allergic or hypersensitive to any of the ingredients in the test products
  • History of disease that could interfere with the test products or impede their absorption
  • Participation in any other clinical trials within past 2 months
  • Renal disease
  • Abnormal hepatic function
  • Under hypolipidemic drugs therapy within past 3 months
  • Under antipsychotic drugs therapy within past 2 months
  • Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
  • History of alcohol or substance abuse
  • Pregnancy or breast feeding

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: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Placebo for 8 weeks
Dietary supplement: Placebo
EXPERIMENTAL: HGE(hydrolyzed ginseng extract)
HGE capsules(2cap/d, 960mg/d) for 8 weeks.
Dietary supplement: HGE (hydrolyzed ginseng extract)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of blood glucose during OGTT(oral glucose tolerance test)
Time Frame: 8 weeks
Changes of fasting and postprandial glucose during OGTT were assessed before(baseline) and after the intervention.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of blood insulin during OGTT.
Time Frame: 8 weeks
Changes of blood insulin during OGTT were assessed before(baseline) and after the intervention.
8 weeks
Changes of glycated albumin, fructosamine, and lipid profile
Time Frame: 8 weeks
Changes of glycated albumin, fructosamine, and lipid profile were assessed before(baseline) and after the intervention
8 weeks

Collaborators and Investigators

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

Sponsor

Chonbuk National University Hospital

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

June 1, 2009

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

May 13, 2013

First Submitted That Met QC Criteria

May 13, 2013

First Posted (ESTIMATE)

May 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 15, 2016

Last Update Submitted That Met QC Criteria

March 13, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ilhwa-FG-001

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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