Blood Glucose, PostprandialPhase 2/3NCT00935350
Reduction of the Glycemic Index by a Novel Viscous Polysaccharide
A Phase 2/3 study testing PolyGlycopleX (PGX) in people with Blood Glucose, Postprandial, run by Glycemic Index Laboratories, Inc at 1 site in Canada.
Trial summary
Reductions of postprandial glucose levels have been demonstrated previously with the addition of a novel viscous polysaccharide (NVP) to a glucose drink and standard white bread. This study explores whether these reductions are sustained when NVP is added to a range of commonly consumed foods. 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)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- May 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 the Novel Fiber, PGX®,to Commonly Consumed Foods on Glycemic Response and Glycemic Index: A Practical and Effective Strategy for Reducing Post Prandial Blood Glucose Levels.
Reductions of postprandial glucose levels have been demonstrated previously with the addition of a novel viscous polysaccharide (NVP) to a glucose drink and standard white bread. This study explores whether these reductions are sustained when NVP is added to a range of commonly consumed foods.
Read the detailed description
Recently, a commercial novel viscous polysaccharide (NVP)complex has been developed which is marketed in both the USA and Canada under the trade name PGX® (PolyGlycopleX) (InovoBiologic Inc, Calgary, AB, Canada). This complex consists of three viscous non starch polysaccharides which are processed using proprietary technology (EnviroSimplex®) to produce compressed granules which delays the onset of viscosity and increases palatability of the fiber when added to food. Previously, this fibre was shown to lower postprandial glucose levels in a dose responsive manner when mixed with a glucose drink and sprinkled onto a standard white bread demonstrating that the processing did not interfere with the effectiveness of the fiber. From this study the reduction in GI was calculated to be 7 units per gram of NVP when added to a solid food, however it is not known whether this relationship would be maintained when the NVP was added to a range of commonly eaten foods. This study therefore evaluates the effect of the addition or incorporation of NVP into a range of foods on postprandial glycemia and whether the reductions in glycemic index could be predicted using.
- Conditions
- Blood Glucose, Postprandial
- Being tested
- PolyGlycopleX (PGX)
- Keywords
- viscous, fibre, polysaccharide, blood glucose, postprandial
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 (PGX)Dietary supplement
5.0 grams of PGX
PolyGlycopleX (PGX)Dietary supplement
0 grams of PGX
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Control White bread containing 50g available carbohydrate Receives: Dietary Supplement: PolyGlycopleX (PGX) |
| 2 | Placebo comparator | White bread and milk control Receives: Dietary Supplement: PolyGlycopleX (PGX) |
| 3 | Placebo comparator | Granola control Receives: Dietary Supplement: PolyGlycopleX (PGX) |
| 4 | Placebo comparator | Cornflakes and milk control Receives: Dietary Supplement: PolyGlycopleX (PGX) |
| 5 | Placebo comparator | White rice control Receives: Dietary Supplement: PolyGlycopleX (PGX) |
| 6 | Placebo comparator | Fruit yogurt control Receives: Dietary Supplement: PolyGlycopleX (PGX) |
| 7 | Placebo comparator | Turkey dinner control Receives: Dietary Supplement: PolyGlycopleX (PGX) |
| 8 | Experimental | Granola Receives: Dietary Supplement: PolyGlycopleX (PGX) |
| 9 | Experimental | Cornflakes and milk Receives: Dietary Supplement: PolyGlycopleX (PGX) |
| 10 | Experimental | White Rice Receives: Dietary Supplement: PolyGlycopleX (PGX) |
| 11 | Experimental | Fruit yogurt Receives: Dietary Supplement: PolyGlycopleX (PGX) |
| 12 | Experimental | Turkey dinner Receives: Dietary Supplement: PolyGlycopleX (PGX) |
| 13 | Placebo comparator | White Bread Receives: Dietary Supplement: PolyGlycopleX (PGX) |
| 14 | Placebo comparator | White bread Receives: Dietary Supplement: PolyGlycopleX (PGX) |
| 15 | Experimental | Granola Receives: Dietary Supplement: PolyGlycopleX (PGX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Blood glucose response of food with and without NVP
Measured: Acute blood glucose response measured at 0, 15,30,45,60,90 and 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startMay 2006
- Primary completionJun 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT00935350
- Sponsor's protocol ID
- GIL-6033
- Status last verified
- Jul 2009
- First submitted
- 25 Mar 2009
- Last updated
- 9 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Jenkins AL, Kacinik V, Lyon M, Wolever TM. Effect of adding the novel fiber, PGX(R), to commonly consumed foods on glycemic response, glycemic index and GRIP: a simple and effective strategy for reducing post prandial blood glucose levels--a randomized, controlled trial. Nutr J. 2010 Nov 22;9:58. doi: 10.1186/1475-2891-9-58.
PubMed 21092221
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding the Novel Fiber, PGX®,to Commonly Consumed Foods on Glycemic Response and Glycemic Index: A Practical and Effective Strategy for Reducing Post Prandial Blood Glucose Levels.
- ClinicalTrials.gov ID
- NCT00935350
- Acronym / sponsor ID
- GIL-6033
- Conditions
- Blood Glucose, Postprandial
- Keywords
- viscous, fibre, polysaccharide, blood glucose, postprandial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Glycemic Index Laboratories, IncIndustry (pharma, biotech, devices)
- Collaborators
- InovoBiologic Inc., Canadian Center for Functional Medicine
- Study start
- May 2006
- Primary completion
- Jun 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 9 Jul 2009 (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.
Reductions of postprandial glucose levels have been demonstrated previously with the addition of a novel viscous polysaccharide (NVP) to a glucose drink and standard white bread. This study explores whether these reductions are sustained when NVP is added to a range of commonly consumed foods.
Detailed description
Recently, a commercial novel viscous polysaccharide (NVP)complex has been developed which is marketed in both the USA and Canada under the trade name PGX® (PolyGlycopleX) (InovoBiologic Inc, Calgary, AB, Canada). This complex consists of three viscous non starch polysaccharides which are processed using proprietary technology (EnviroSimplex®) to produce compressed granules which delays the onset of viscosity and increases palatability of the fiber when added to food. Previously, this fibre was shown to lower postprandial glucose levels in a dose responsive manner when mixed with a glucose drink and sprinkled onto a standard white bread demonstrating that the processing did not interfere with the effectiveness of the fiber. From this study the reduction in GI was calculated to be 7 units per gram of NVP when added to a solid food, however it is not known whether this relationship would be maintained when the NVP was added to a range of commonly eaten foods. This study therefore evaluates the effect of the addition or incorporation of NVP into a range of foods on postprandial glycemia and whether the reductions in glycemic index could be predicted using.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Dietary Supplement: PolyGlycopleX (PGX)Control White bread containing 50g available carbohydrate |
| 2 | Placebo comparator | Dietary Supplement: PolyGlycopleX (PGX)White bread and milk control |
| 3 | Placebo comparator | Dietary Supplement: PolyGlycopleX (PGX)Granola control |
| 4 | Placebo comparator | Dietary Supplement: PolyGlycopleX (PGX)Cornflakes and milk control |
| 5 | Placebo comparator | Dietary Supplement: PolyGlycopleX (PGX)White rice control |
| 6 | Placebo comparator | Dietary Supplement: PolyGlycopleX (PGX)Fruit yogurt control |
| 7 | Placebo comparator | Dietary Supplement: PolyGlycopleX (PGX)Turkey dinner control |
| 8 | Experimental | Dietary Supplement: PolyGlycopleX (PGX)Granola |
| 9 | Experimental | Dietary Supplement: PolyGlycopleX (PGX)Cornflakes and milk |
| 10 | Experimental | Dietary Supplement: PolyGlycopleX (PGX)White Rice |
| 11 | Experimental | Dietary Supplement: PolyGlycopleX (PGX)Fruit yogurt |
| 12 | Experimental | Dietary Supplement: PolyGlycopleX (PGX)Turkey dinner |
| 13 | Placebo comparator | Dietary Supplement: PolyGlycopleX (PGX)White Bread |
| 14 | Placebo comparator | Dietary Supplement: PolyGlycopleX (PGX)White bread |
| 15 | Experimental | Dietary Supplement: PolyGlycopleX (PGX)Granola |
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 | 15, 8 |
| PolyGlycopleX (PGX)5.0 grams of PGX | Dietary supplement | 10, 11, 12, 8, 9 |
| PolyGlycopleX (PGX)0 grams of PGX | Dietary supplement | 1, 13, 14, 2, 3, 4, 5, 6, 7 |
Primary outcome
Relative Blood glucose response of food with and without NVP
Time frame: Acute blood glucose response measured at 0, 15,30,45,60,90 and 120 min
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 9 Jul 2009.
- Derived from this study: PubMed 21092221Jenkins AL, Kacinik V, Lyon M, Wolever TM. Effect of adding the novel fiber, PGX(R), to commonly consumed foods on glycemic response, glycemic index and GRIP: a simple and effective strategy for reducing post prandial blood glucose levels--a randomized, controlled trial. Nutr J. 2010 Nov 22;9:58. doi: 10.1186/1475-2891-9-58.
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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) 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 9 Jul 2009. 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?
Relative Blood glucose response of food with and without NVP (time frame: Acute blood glucose response measured at 0, 15,30,45,60,90 and 120 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00935350, which also lists 1 linked publication.
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 9 Jul 2009.