HyperglycemiaPhase 3NCT00367926
The Effect of American Ginseng Root and Its Components on Glycemia in Healthy Individuals
A Phase 3 study testing American ginseng root / polysaccharides in people with Hyperglycemia, run by Risk Factor Modification Centre at 1 site in Canada.
Trial summary
To determine the effect of polysaccharides from American ginseng root on postprandial glycemia in healthy individuals. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- American ginseng root / polysaccharides
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2005to Jul 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 16-65 years old
- normal renal and hepatic function
- fasting plasma glucose: 4-6 mmol/l
- clinically euthyroid
- normotensive
Who cannot join
- pregnant
- taking herbs, supplements or medication that affect glycemia
- major illnesses/ disease
- heavy alcohol use (> 3 drinks/ day)
- heavy smoking (> 10 cigarettes/ day)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of American Ginseng Root and Derived Polysaccharides on Postprandial Glycemia in Healthy Individuals
To determine the effect of polysaccharides from American ginseng root on postprandial glycemia in healthy individuals.
Read the 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.
- Conditions
- Hyperglycemia
- Being tested
- American ginseng root / polysaccharides
- Keywords
- ginseng, polysaccharides, postprandial glycemia, area under the glucose curve, peak incremental glucose
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
American ginseng root / polysaccharidesDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
incremental area under the postprandial glucose curve
incremental peak postprandial glucose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2006 (estimated)
- Study startJun 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- Risk Factor Modification Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Ontario Ginseng Growers Association
- Investigators
- Vladimir Vuksan, Ph.D., Principal investigator, St. Michael's Hospital/ University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367926
- Sponsor's protocol ID
- RFMC-0001-103
- Other IDs
- MOP- 62943
- Status last verified
- Sep 2005
- First submitted
- 22 Aug 2006
- Last updated
- 23 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of American Ginseng Root and Derived Polysaccharides on Postprandial Glycemia in Healthy Individuals
- ClinicalTrials.gov ID
- NCT00367926
- Acronym / sponsor ID
- RFMC-0001-103
- Conditions
- Hyperglycemia
- Keywords
- ginseng, polysaccharides, postprandial glycemia, area under the glucose curve, peak incremental glucose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- Risk Factor Modification CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Ontario Ginseng Growers Association
- Study start
- Jun 2005
- Study completion
- Jul 2005
- First posted
- 23 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 16-65 years old
- normal renal and hepatic function
- fasting plasma glucose: 4-6 mmol/l
- clinically euthyroid
- normotensive
Key exclusion criteria (5 listed)
- pregnant
- taking herbs, supplements or medication that affect glycemia
- major illnesses/ disease
- heavy alcohol use (> 3 drinks/ day)
- heavy smoking (> 10 cigarettes/ day)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| American ginseng root / polysaccharides | Drug | – |
Primary outcome
incremental area under the postprandial glucose curve
incremental peak postprandial glucose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Vuksan, Ph.D. principal investigator
St. Michael's Hospital/ University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing American ginseng root / polysaccharides in people with Hyperglycemia, run by Risk Factor Modification Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incremental area under the postprandial glucose curve. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2006.