The Effect of American Ginseng Root and Its Components on Glycemia in Healthy Individuals

Hyperglycemia Clinical Trial

Official title:

Effect of American Ginseng Root and Derived Polysaccharides on Postprandial Glycemia in Healthy Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00367926
• Other study ID #: RFMC-0001-103
• Secondary ID: MOP- 62943
• Status: Completed
• Phase: Phase 3
• First received: August 22, 2006
• Last updated: August 22, 2006
• Start date: June 2005
• Est. completion date: July 2005

Study information

• Verified date: September 2005
• Source: Risk Factor Modification Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

To determine the effect of polysaccharides from American ginseng root on postprandial glycemia in healthy individuals.

Description:

Glycemia-lowering effects of American ginseng root have been repeatedly observed in healthy individuals and in type 2 diabetes. It is unclear which components trigger these effects. Pre-clinical evidence suggests that, aside from ginseng saponins, ginseng polysaccharides may reduce glycemia. This assumption has not been investigated so far in humans.

We therefore undertook a double-blind randomized controlled clinical trial to determine the effect of American ginseng root polysaccharides, at escalating doses, on postprandial glycemia, in comparison to the American ginseng root and control in healthy individuals. We hypothesized that polysaccharides will reduce glycemia comparably to a dose of ginseng root that contains polysaccharides at an equivalent amount to the average polysaccharide dose. We therefore tested polysaccharide doses equivalent to 9, 12 and 15 g of rot, 12 go of ginseng root and a wheat bran control. Each subject received each treatment in random sequence, after a 12-hour overnight fast and 40 minutes prior to a 25-g oral glucose tolerance test. Capillary blood samples were collected at baseline, prior to glucose ingestion and at 15, 30, 45, 60, 90, 120 minutes after the start of glucose intake. Capillary blood glucose was measured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

• 16-65 years old

• normal renal and hepatic function

• fasting plasma glucose: 4-6 mmol/l

• clinically euthyroid

• normotensive

Exclusion Criteria:

• pregnant

• taking herbs, supplements or medication that affect glycemia

• major illnesses/ disease

• heavy alcohol use (> 3 drinks/ day)

• heavy smoking (> 10 cigarettes/ day)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperglycemia

Intervention

Drug:
• American ginseng root / polysaccharides

Locations

Country	Name	City	State
Canada	Risk Factor Modification Centre	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Risk Factor Modification Centre	Canadian Institutes of Health Research (CIHR), Ontario Ginseng Growers Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incremental area under the postprandial glucose curve
Primary	incremental peak postprandial glucose