The Effect of Korean Red Ginseng Supplementation on Glucose Control

Phase 4

Completed

• Conditions: Diabetes
• Interventions: Dietary Supplement: KRG; Dietary Supplement: Placebo

• Registration Number: NCT01911663
• Lead Sponsor: Yonsei University

Brief Summary

This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of Korean red ginseng supplementation on glucose control in subjects with impaired fasting glucose, impaired glucose tolerance or newly-diagnosed type 2 Diabetes Mellitus and to establish a clinical evidence on glucose control effect of KRG.

Detailed Description

Study participants, who were all aged between 20 and 70, were recruited from health checkup center at Ilsan hospital (Gyeonggi-do, Korea) and the advertisements in local newspaper. After the glucose screening test, subjects with IFG (100 mg/dL ≤ fasting blood glucose ≤ 125mg/dL), IGT (140mg/dL ≤ 2-h OGTT), or newly-diagnosed T2DM (fasting glucose ≥ 126 mg/dL) were enrolled in this study. Exclusion criteria that all selected patients met were: 1) Taking glucose-lowering medications or having insulin injections. 2) Chronic alcoholism or having an evidence or alcoholism. 3) Pregnant or in breast feeding. 4) Having chronic gastrointestinal disorders. 5) Showing signs of nutrient deficiency of malnutrition. 6) Patients with serious kidney problems. 7) Patients with serious liver problems. 8) Patients whose job could be a threat when hypoglycemia occurs. 9) Patients who have experienced the complications such as headache, insomnia, heart palpitations and raised blood pressure after eating red ginseng. 10) Other patients who were considered unsuitable for this study by the researchers

This study was designed for 12-week randomized, double-blinded, placebo-controlled trial. Sixty subjects were randomly assigned to receive placebo (corn starch) or 500 mg KRG. Both group consumed 10 capsules per day, three times daily after breakfast (3 capsules), lunch (3 capsules) and dinner (4 capsules), and it comes to total 5.0g daily. Red ginseng and placebo capsules were provided by the Korea Ginseng Cooperation (KGC, Daejeon, Korea).

Subjects met with the investigational team at four different time points: Screening (Week -1), randomization and treatment baseline (Week 0), treatment midpoint (Week 6), and treatment endpoint (Week 12). Daily intake by 24-hour recall method and physical activity were measured at baseline (Week 0), midpoint (Week 6), and endpoint (Week 12) of the treatment period. Compliance with study restrictions and capsule consumption was monitored via daily documentation by subjects on individualized study calendars and end-study count of returned capsules.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2012-02
• Study Completion: 2012-03
• Status Verified: 2013-07
• Study First Submitted: 2013-07-26
• Study First Submitted QC: 2013-07-26
• Last Update Submitted: 2013-07-26
• Study First Posted: 2013-07-30
• Last Update Posted: 2013-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• subjects with IFG (100 mg/dL ≤ fasting blood glucose ≤ 125mg/dL), IGT (140mg/dL ≤ 2-h OGTT), or newly-diagnosed T2DM (fasting glucose ≥ 126 mg/dL) were enrolled in this study.

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Exclusion Criteria

• Exclusion criteria that all selected patients met were: 1) Taking glucose-lowering medications or having insulin injections. 2) Chronic alcoholism or having an evidence or alcoholism. 3) Pregnant or in breast feeding. 4) Having chronic gastrointestinal disorders. 5) Showing signs of nutrient deficiency of malnutrition. 6) Patients with serious kidney problems. 7) Patients with serious liver problems. 8) Patients whose job could be a threat when hypoglycemia occurs. 9) Patients who have experienced the complications such as headache, insomnia, heart palpitations and raised blood pressure after eating red ginseng. 10) Other patients

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KRG	KRG	500 mg Korea red ginseng (KRG)
Placebo	Placebo	500 mg placebo (corn starch)

Primary Outcome Measures

Name	Time	Method
change from baseline in glucose	12 week

Secondary Outcome Measures

Name	Time	Method
change from baseline in insulin	12 week
change from baseline in C-peptide	12 week

Trial Locations

Locations (1)

Laboratory of clinical Nutrigenetics/Nutrigenomic; 🇰🇷 Seoul, Korea, Republic of