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Hypoglycemic Effects of Fermented Red Ginseng in Subject With Impaired Fasting Glucose or Type 2 Diabetes

NCT ID: NCT01826409

Last Updated: 2013-08-29

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

PHASE2/PHASE3

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Brief Summary

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This study was conducted to investigate the effects of daily supplementation of fermented red ginseng (FRG) on glycemic status in subjects with impaired fasting glucose (IFG) or type 2 diabetes.

Detailed Description

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This study was a 4 weeks, randomized, double-blind, placebo-controlled trial. Forty-two subjects with IFG or type 2 diabetes were randomly allocated to 2 groups to consume placebo or FRG three times per day for 4 weeks. Fasting and postprandial glucose profiles during meal tolerance test were assessed before and after the intervention.

Conditions

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Impaired Glucose or Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fermented red ginseng

Group Type EXPERIMENTAL

Fermented Red Ginseng

Intervention Type DIETARY_SUPPLEMENT

Fermented red ginseng 2.7g/day for 4 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo 2.7g/day for 4 weeks

Interventions

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Fermented Red Ginseng

Fermented red ginseng 2.7g/day for 4 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo 2.7g/day for 4 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Age 20-75 years with fasting glucose 100\~140 mg/dL at least two of the following

Exclusion Criteria

* Lipid metabolic disorder
* Acute or chronic inflammatory disease
* Taking medication of corticosteroid within 4 weeks of the study
* Cardiovascular disease (arrhythmia, heart failure, myocardial infarction or patient with pacemaker)
* Allergic or hypersensitive to any of the ingredients in the test products
* Participation in other clinical trials within 2 months
* Abnormal hepatic liver function or renal disease (acute/chronic renal failure or nephrotic syndrome)
* Taking medication of lipid phosphates within 3 months of the study etc,
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

Principal Investigators

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Tae Sun Park, MD., PhD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Locations

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Clincial Trial Center for Functional Foods

Jeonju, Jeollabok-do, South Korea

Site Status

Countries

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South Korea

References

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Oh MR, Park SH, Kim SY, Back HI, Kim MG, Jeon JY, Ha KC, Na WT, Cha YS, Park BH, Park TS, Chae SW. Postprandial glucose-lowering effects of fermented red ginseng in subjects with impaired fasting glucose or type 2 diabetes: a randomized, double-blind, placebo-controlled clinical trial. BMC Complement Altern Med. 2014 Jul 11;14:237. doi: 10.1186/1472-6882-14-237.

Reference Type DERIVED
PMID: 25015735 (View on PubMed)

Other Identifiers

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WKP-FG7070-001

Identifier Type: -

Identifier Source: org_study_id