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

Primary Purpose

Hyperglycemia

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
American ginseng root / polysaccharides
Sponsored by
Risk Factor Modification Centre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperglycemia focused on measuring ginseng, polysaccharides, postprandial glycemia, area under the glucose curve, peak incremental glucose

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Risk Factor Modification Centre

Outcomes

Primary Outcome Measures

incremental area under the postprandial glucose curve
incremental peak postprandial glucose

Secondary Outcome Measures

Full Information

First Posted
August 22, 2006
Last Updated
August 22, 2006
Sponsor
Risk Factor Modification Centre
Collaborators
Canadian Institutes of Health Research (CIHR), Ontario Ginseng Growers Association
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1. Study Identification

Unique Protocol Identification Number
NCT00367926
Brief Title
The Effect of American Ginseng Root and Its Components on Glycemia in Healthy Individuals
Official Title
Effect of American Ginseng Root and Derived Polysaccharides on Postprandial Glycemia in Healthy Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Risk Factor Modification Centre
Collaborators
Canadian Institutes of Health Research (CIHR), Ontario Ginseng Growers Association

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia
Keywords
ginseng, polysaccharides, postprandial glycemia, area under the glucose curve, peak incremental glucose

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
12 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
American ginseng root / polysaccharides
Primary Outcome Measure Information:
Title
incremental area under the postprandial glucose curve
Title
incremental peak postprandial glucose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir Vuksan, Ph.D.
Organizational Affiliation
St. Michael's Hospital/ University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Risk Factor Modification Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2T2
Country
Canada

12. IPD Sharing Statement

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

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