Effect of Korean Red Ginseng on Insulin Sensitivity in Non Diabetic Overweight Korean Adults

NCT01616134 | Completed

• 1 other identifier: KRG-0912
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Korean red ginseng (KRG) is popular worldwide since it is believed to contain ingredients with a variety of health enhancement effects. Several in vitro studies and animal studies showed that ginseng has anti-obesity, anti-diabetic and anti-metabolic disease effects. Several studies involving type 2 diabetes mellitus (T2DM) patients reported that administration of KRG for 12 weeks resulted in positive effects on the maintenance of sugar control effect and improvement of insulin resistance Although there is evidence to suggest that KRG could efficacious reduction in postprandial glycemia, the benefits of long-term KRG in healthy individuals on insulin sensitivity has not yet been established. Therefore, we investigated whether KRG affected insulin sensitivity in healthy overweight or obese Korean subjects without overt diabetes.

Conditions

Insulin Resistance; Obesity

Keywords

overweight,; ginseng

Outcome Measures

Primary Outcomes (1)

• insulin sensitivity (insulin, HOMA-IR, QUICKI)

  Blood samples after a 12-h fast were taken at baseline and 12 weeks after randomization. Blood samples were taken after at least 8 hours of fasting for glucose, insulin, liver enzyme, creatinine and lipid test. The homeostasis model assessment index-insulin resistance (HOMA-IR) was calculated using a fomula: \[fasting plasma insulin (µU/mL) × fasting plasma glucose (mg/dL)\] / (22.5×18.182) and quantitative insulin-sensitivity check index (QUICKI) was calculated using a formula: 1 / \[log fasting insulin (µU/mL) + log fasting blood sugar (mg/dL)\]

  12 weeks

Study Arms (2)

Korea Red Ginseng

ACTIVE COMPARATOR

Intervention group were administered with 4 capsules (2 g) each of powdered red ginseng (6-year old , rootlets) 40 minutes before breakfast, lunch and dinner, totaling 12 capsules (6 g) per day, for 12 weeks.

Other: Korea red ginseng

placebo contating constarch

PLACEBO COMPARATOR

Other: Placebo

Interventions

Korea red ginseng OTHER

Intervention group were administered with 4 capsules (2 g) each of powdered red ginseng (6-year old , rootlets) 40 minutes before breakfast, lunch and dinner, totaling 12 capsules (6 g) per day, for 12 weeks

Korea Red Ginseng

Placebo OTHER

The subjects in the Control group were given the same quantity of placebos also three times a day for 12 weeks.

placebo contating constarch

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ages of 20 and 60 years
• BMI ≥ 23 kg/m2

You may not qualify if:

• any supplements or medications, including anti-diabetic drugs, anti-hypertensive drugs, steroids, or hormonal products, during the previous 4 weeks
• participant's systolic BP was above 140 mmHg or diastolic BP above 90 mmHg
• above 100 m/dL before enrollment in the study

Sponsors & Collaborators

• The Korean Society of Ginseng: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 626-770, South Korea

Location

MeSH Terms

Conditions

Insulin Resistance; Obesity; Overweight

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pusan national iniversity Yangsan Hospital

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 11, 2012
• Study Start: August 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

KR (1)