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

August 22, 2006 updated by: Risk Factor Modification Centre

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment

12

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5C 2T2
        • Risk Factor Modification Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
incremental area under the postprandial glucose curve
incremental peak postprandial glucose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Risk Factor Modification Centre

Collaborators

Canadian Institutes of Health Research (CIHR)
Ontario Ginseng Growers Association

Investigators

  • Principal Investigator: Vladimir Vuksan, Ph.D., St. Michael's Hospital/ University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion

July 1, 2005

Study Registration Dates

First Submitted

August 22, 2006

First Submitted That Met QC Criteria

August 22, 2006

First Posted (Estimate)

August 23, 2006

Study Record Updates

Last Update Posted (Estimate)

August 23, 2006

Last Update Submitted That Met QC Criteria

August 22, 2006

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RFMC-0001-103
  • MOP- 62943

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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