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

NCT ID: NCT00367926

Last Updated: 2006-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2005-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hyperglycemia

Keywords

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ginseng polysaccharides postprandial glycemia area under the glucose curve peak incremental glucose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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American ginseng root / polysaccharides

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Ontario Ginseng Growers Association

OTHER

Sponsor Role collaborator

Risk Factor Modification Centre

OTHER

Sponsor Role lead

Principal Investigators

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Vladimir Vuksan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

St. Michael's Hospital/ University of Toronto

Locations

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Risk Factor Modification Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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MOP- 62943

Identifier Type: -

Identifier Source: secondary_id

RFMC-0001-103

Identifier Type: -

Identifier Source: org_study_id