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
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
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
NCT ID
NCT00367926
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
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
Learn more about this trial
The Effect of American Ginseng Root and Its Components on Glycemia in Healthy Individuals
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