NCT00367926

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2006

Completed
Last Updated

August 23, 2006

Status Verified

September 1, 2005

First QC Date

August 22, 2006

Last Update Submit

August 22, 2006

Conditions

Hyperglycemia

Keywords

ginsengpolysaccharidespostprandial glycemiaarea under the glucose curvepeak incremental glucose

Outcome Measures

Primary Outcomes (2)

  • incremental area under the postprandial glucose curve

  • incremental peak postprandial glucose

Interventions

American ginseng root / polysaccharidesDRUG

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • normal renal and hepatic function
  • fasting plasma glucose: 4-6 mmol/l
  • clinically euthyroid
  • normotensive

You may not qualify if:

  • pregnant
  • taking herbs, supplements or medication that affect glycemia
  • major illnesses/ disease
  • heavy alcohol use (\> 3 drinks/ day)
  • heavy smoking (\> 10 cigarettes/ day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Risk Factor Modification Centre

Toronto, Ontario, M5C 2T2, Canada

Location

MeSH Terms

Conditions

Hyperglycemia

Interventions

Polysaccharides

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • Vladimir Vuksan, Ph.D.

    St. Michael's Hospital/ University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2006

First Posted

August 23, 2006

Study Start

June 1, 2005

Study Completion

July 1, 2005

Last Updated

August 23, 2006

Record last verified: 2005-09

Locations

CA(1)