Blood Glucose, PostprandialPhase 2/3NCT00801814
Effect of Escalating Doses of a Novel Viscous Polysaccharide on Postprandial Glycemia
A Phase 2/3 study testing PolyGlycopleX (PGX), PolyGlycopleX (PG) and PolyGlycopleX in people with Blood Glucose, Postprandial, run by Glycemic Index Laboratories, Inc at 1 site in Canada.
Trial summary
To determine palatability and extent to which escalating doses of a novel highly viscous polysaccharide [NVP] reduces postprandial glycemia when added to a liquid and a solid meal. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose, Postprandial
- What is being tested?
- PolyGlycopleX (PGX), PolyGlycopleX (PG) and PolyGlycopleX
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2006to Aug 2006
- Phase
- Phase 2/3
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy individuals
- 18-75 years old
- BMI less than 35 kg/m2
Who cannot join
- Medications influencing gastrointestinal function
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Adding Escalating Doses of a Novel Highly Viscous Polysaccharide to Either a Liquid or a Solid Test Meal on Post Prandial Glycemia in Healthy Subjects: Determination of the Glycemic Reduction Index Potential (GRIP)
To determine palatability and extent to which escalating doses of a novel highly viscous polysaccharide [NVP] reduces postprandial glycemia when added to a liquid and a solid meal.
- Conditions
- Blood Glucose, Postprandial
- Being tested
- PolyGlycopleX (PGX), PolyGlycopleX (PG), PolyGlycopleX, Control, Second Control
- Keywords
- viscous, fibre, polysaccharide, blood glucose, post prandial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolyGlycopleX (PGX)Dietary supplement
2.5 grams of PGX
PolyGlycopleX (PG)Dietary supplement
5.0 grams of PGX
PolyGlycopleXDietary supplement
7.5 grams of PGX
ControlDietary supplement
0g of PGX
Second ControlDietary supplement
0g of PGX
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | White Bread Receives: Dietary Supplement: Control |
| 2 | Placebo comparator | White Bread and Margarine Control Receives: Dietary Supplement: Second Control |
| 3 | Placebo comparator | Glucose drink control Receives: Dietary Supplement: Control |
| 4 | Experimental | White bread and margarine
or
Glucose drink Receives: Dietary Supplement: PolyGlycopleX (PGX); Dietary Supplement: PolyGlycopleX (PG); Dietary Supplement: PolyGlycopleX |
| 5 | Experimental | White bread and margarine
or
Glucose drink Receives: Dietary Supplement: PolyGlycopleX (PGX); Dietary Supplement: PolyGlycopleX (PG); Dietary Supplement: PolyGlycopleX |
| 6 | Experimental | White bread and margarine
or
Glucose drink Receives: Dietary Supplement: PolyGlycopleX (PGX); Dietary Supplement: PolyGlycopleX (PG); Dietary Supplement: PolyGlycopleX |
What is being measured
The primary outcome is the main question the study is designed to answer.
postprandial glycemia
Measured: Acute study measuring postprandial glucose levels over 2 hours
Secondary outcomes (1)
The glucose reduction index potential (GRIP). The GRIP factor is the reduction in glycemic index units per gram of fiber.
Measured: Data analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startApr 2006
- Primary completionMay 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Glucose, PostprandialStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glycemic Index Laboratories, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- InovoBiologic Inc., Canadian Center for Functional Medicine
- Investigators
- Alexandra L Jenkins, PhD, RD, Study director, Glycemic Index Laboratories, IncThomas MS Wolever, MD, Principal investigator, Glycemic Index Laboratories, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801814
- Sponsor's protocol ID
- GIL-5051
- Status last verified
- Dec 2008
- First submitted
- 3 Dec 2008
- Last updated
- 4 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Escalating Doses of a Novel Highly Viscous Polysaccharide to Either a Liquid or a Solid Test Meal on Post Prandial Glycemia in Healthy Subjects: Determination of the Glycemic Reduction Index Potential (GRIP)
- ClinicalTrials.gov ID
- NCT00801814
- Acronym / sponsor ID
- GIL-5051
- Conditions
- Blood Glucose, Postprandial
- Keywords
- viscous, fibre, polysaccharide, blood glucose, post prandial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Glycemic Index Laboratories, IncIndustry (pharma, biotech, devices)
- Collaborators
- InovoBiologic Inc., Canadian Center for Functional Medicine
- Study start
- Apr 2006
- Primary completion
- May 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 4 Dec 2008 (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 palatability and extent to which escalating doses of a novel highly viscous polysaccharide [NVP] reduces postprandial glycemia when added to a liquid and a solid meal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Dietary Supplement: ControlWhite Bread |
| 2 | Placebo comparator | Dietary Supplement: Second ControlWhite Bread and Margarine Control |
| 3 | Placebo comparator | Dietary Supplement: ControlGlucose drink control |
| 4 | Experimental | Dietary Supplement: PolyGlycopleX (PGX), Dietary Supplement: PolyGlycopleX (PG), Dietary Supplement: PolyGlycopleXWhite bread and margarine or Glucose drink |
| 5 | Experimental | Dietary Supplement: PolyGlycopleX (PGX), Dietary Supplement: PolyGlycopleX (PG), Dietary Supplement: PolyGlycopleXWhite bread and margarine or Glucose drink |
| 6 | Experimental | Dietary Supplement: PolyGlycopleX (PGX), Dietary Supplement: PolyGlycopleX (PG), Dietary Supplement: PolyGlycopleXWhite bread and margarine or Glucose drink |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy individuals
- 18-75 years old
- BMI less than 35 kg/m2
Key exclusion criteria (2 listed)
- Medications influencing gastrointestinal function
- Pregnancy
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 |
|---|---|---|
| PolyGlycopleX (PGX)2.5 grams of PGX | Dietary supplement | 4, 5, 6 |
| PolyGlycopleX (PG)5.0 grams of PGX | Dietary supplement | 4, 5, 6 |
| PolyGlycopleX7.5 grams of PGX | Dietary supplement | 4, 5, 6 |
| Control0g of PGX | Dietary supplement | 1, 3 |
| Second Control0g of PGX | Dietary supplement | 2 |
Primary outcome
postprandial glycemia
Time frame: Acute study measuring postprandial glucose levels over 2 hours
1 secondary outcome
The glucose reduction index potential (GRIP). The GRIP factor is the reduction in glycemic index units per gram of fiber.
Time frame: Data analysis
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 4 Dec 2008.
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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.
Alexandra L Jenkins, PhD, RD study director
Glycemic Index Laboratories, Inc
Thomas MS Wolever, MD principal investigator
Glycemic Index Laboratories, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PolyGlycopleX (PGX), PolyGlycopleX (PG) and PolyGlycopleX in people with Blood Glucose, Postprandial, run by Glycemic Index Laboratories, Inc 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 3 inclusion and 2 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 4 Dec 2008. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
postprandial glycemia (time frame: Acute study measuring postprandial glucose levels over 2 hours). 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 4 Dec 2008.