The Effect of Korean Red Ginseng Supplementation on Glucose Control

Diabetes Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01911663
• Other study ID #: KGC-CKJ-PC
• Status: Completed
• Phase: Phase 4
• First received: July 26, 2013
• Last updated: July 26, 2013
• Start date: November 2011
• Est. completion date: March 2012

Study information

• Verified date: July 2013
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes

Intervention

Dietary Supplement:
• KRG
500 mg Korea red ginseng (KRG)
• Placebo
500 mg placebo

Locations

Country	Name	City	State
Korea, Republic of	Laboratory of clinical Nutrigenetics/Nutrigenomic	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in glucose		12 week	Yes
Secondary	change from baseline in insulin		12 week	Yes
Secondary	change from baseline in C-peptide		12 week	Yes