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

Phase 2

Completed

• Conditions: Impaired Glucose or Type 2 Diabetes
• Interventions: Dietary Supplement: Fermented Red Ginseng; Dietary Supplement: Placebo

• Registration Number: NCT01826409
• Lead Sponsor: Chonbuk National University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2009-09
• Study First Submitted: 2013-04-04
• Study First Submitted QC: 2013-04-05
• Study First Posted: 2013-04-08
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-28
• Last Update Posted: 2013-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fermented red ginseng	Fermented Red Ginseng	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Glucose profiles during meal tolerance test	4 weeks	Fasting and postprandial glucose profiles during meal tolerance test were assessed before(baseline) and after the intervention

Secondary Outcome Measures

Name	Time	Method
Change in lipid profiles	4 weeks	Change in lipid profiles were assessed before(baseline) and after the intervention

Trial Locations

Locations (1)

Clincial Trial Center for Functional Foods; 🇰🇷 Jeonju, Jeollabok-do, Korea, Republic of