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Completed

NCT Number: NCT00367926

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

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

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Key information

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Risk Factor Modification Centre

Toronto, Ontario, M5C 2T2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

American ginseng root / polysaccharides

Drug

Primary outcomes

  1. incremental area under the postprandial glucose curve

  2. incremental peak postprandial glucose

Sponsors and collaborators

Lead sponsor

Risk Factor Modification Centre

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2005
First posted
Aug 23, 2006
Registry last updated
Aug 23, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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