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

Study Overview
=================
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.

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

Conditions
-----------------
Hyperglycemia

Intervention / Treatment
-----------------
* Drug: American ginseng root / polysaccharides


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: American ginseng root / polysaccharides|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incremental area under the postprandial glucose curve |  |  | 
| incremental peak postprandial glucose |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ginseng, polysaccharides, postprandial glycemia, area under the glucose curve, peak incremental glucose