Efficacy and Safety of Hydrolyzed Ginseng Extract on Impaired Fasting Glucose

NCT ID: NCT01854164

Last Updated: 2016-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Hyperglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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HGE(hydrolyzed ginseng extract)

HGE capsules(2cap/d, 960mg/d) for 8 weeks.

Group Type EXPERIMENTAL

HGE (hydrolyzed ginseng extract)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo for 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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HGE (hydrolyzed ginseng extract)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo-Wan Chae

Principal Investigator, Clinical Trial Center for Functional Foods

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical Trial Center for Functional Foods, Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Ilhwa-FG-001

Identifier Type: -

Identifier Source: org_study_id

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