Efficacy and Safety of Hydrolyzed Ginseng Extract on Impaired Fasting Glucose

Chonbuk National University Hospital20 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Hyperglycemia

Interventions

HGE (hydrolyzed ginseng extract)DIETARY_SUPPLEMENT

PlaceboDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Clinical Trial Center for Functional Foods, Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Outcomes

Primary Outcomes

Changes of blood glucose during OGTT(oral glucose tolerance test)

Changes of fasting and postprandial glucose during OGTT were assessed before(baseline) and after the intervention.

Time frame: 8 weeks

Secondary Outcomes

Changes of blood insulin during OGTT.

Changes of blood insulin during OGTT were assessed before(baseline) and after the intervention.

Time frame: 8 weeks

Changes of glycated albumin, fructosamine, and lipid profile

Changes of glycated albumin, fructosamine, and lipid profile were assessed before(baseline) and after the intervention

Time frame: 8 weeks

Data from ClinicalTrials.gov

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