Skip to main content
OpenTrials
Completed

NCT Number: NCT01911663

The Effect of Korean Red Ginseng Supplementation on Glucose Control

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Laboratory of clinical Nutrigenetics/Nutrigenomic

Seoul, 120-749, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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

Treatment and study plan

KRG

Dietary Supplement

500 mg Korea red ginseng (KRG)

Placebo

Dietary Supplement

500 mg placebo

Primary outcomes

  1. change from baseline in glucose

    Time frame: 12 week

Secondary outcomes

  1. change from baseline in insulin

    Time frame: 12 week

  2. change from baseline in C-peptide

    Time frame: 12 week

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 30, 2013
Registry last updated
Jul 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.