Type 2 DiabetesNCT00728143
Blood Glucose Response to Highly Viscous Polysaccharide Enriched Biscuits in Healthy and Diabetic Subjects
A study testing Highly viscous polysaccharide enriched biscuits in people with Type 2 Diabetes, run by Unity Health Toronto.
Trial summary
Our objective was to test whether the highly viscous polysaccharide incorporated into the biscuit formulation would reduce the postprandial blood glucose response equally in healthy subjects and individuals with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Highly viscous polysaccharide enriched biscuits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Aug 1989to Nov 1989
- Phase
- Interventional
- 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
- males or non-pregnant females aged 18-75 years and in good health;
- BMI <30 kg/m2.
- documented type 2 diabetes for at least 6 month duration without clinically manifest complications;
- age 18-75 years;
- BMI <30 kg/m2.
Who cannot join
- known history of hepatitis, diabetes or a heart condition;
- using medications or fiber supplements;
- any health condition which might affect the results;
- non-compliance with the experimental procedures.
- liver or kidney disease;
- gastrointestinal problems;
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- using fiber supplements;
- non-compliance with the experimental procedures;
- pregnancy.
About this study
Official title: Therapeutic Trials of Low Glycemic Index Foods and Dietary Fiber in the Management of Diabetes, Hyperlipidemia and Renal Disease
Our objective was to test whether the highly viscous polysaccharide incorporated into the biscuit formulation would reduce the postprandial blood glucose response equally in healthy subjects and individuals with type 2 diabetes.
Read the detailed description
Despite significant achievements in treatment modalities and preventive measures, diabetes has been increasing exponentially. Reduction in both fasting and prolonged postprandial glycemia is of paramount importance in the disease prevention and the delay of diabetic complications. Blood glucose concentration can be reduced by dietary means, and may be influenced by factors such as type and amount of carbohydrate, nature of starch, quantity of protein and fat, dietary fiber content, method of food processing, particle size and food form. Glycemic index (GI) is a measure of the blood glucose-raising ability of the available carbohydrate in foods. Although evidence is often insufficient and individual differences occur, prospective studies and clinical trials have shown that low-GI diets may reduce the risk of diabetes and improve glycemic control in diabetes.
High postprandial plasma glucose level can increase severity of diabetes and foods which raise the blood glucose level least for a given carbohydrate content are most suitable for individuals with type 2 diabetes. Lower postprandial glycemia is also important for healthy subjects to prevent diabetes.
High fiber diets have been recommended for the general population and for the nutritional management of patients with type 2 diabetes. Soluble dietary fiber retards digestion and absorption of the associated dietary carbohydrate, thus flattening the postprandial rise in plasma glucose and insulin concentrations. Some foods such as beta-glucan fiber containing oats and barley, and soluble fibers isolates such as pectin, guar, psyllium, or glucomannan have a high viscosity which gives them the greatest blood glucose lowering effect. Viscous fibers, as a result of their rheological properties, form gel with the food and human digesta and consequently reduce postprandial increases in plasma glucose concentrations in both normal and diabetic subjects in positive relation to their level of viscosity. Insoluble fibers such as cellulose and wheat bran have little effect.
The highly viscous polysaccharide (HVP) added to the study biscuit formulation is a blend of highly viscous soluble fibers (polysaccharides) that act synergistically to develop a higher level of viscosity than any other known dietary fiber in nature. One of the main components of the HVP is glucomannan, a glucose-mannose polysaccharide obtained from grinding the tuber root of Amorphophallus Konjac C. Koch, a plant that has been used as food and remedy for thousands of years in the Far East. Highly refined glucomannan is 3 times more viscous than guar and approximately 7 times more viscous than psyllium. The viscosity of the HVP is amplified further with a viscosity 3-5 times higher than glucomannan alone used in formulation, that is considered to be the highest viscosity single dietary fiber. Previously we and others have shown that the higher viscosity in vitro directly corresponded to lower blood glucose.
- Conditions
- Type 2 Diabetes
- Being tested
- Highly viscous polysaccharide enriched biscuits
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Highly viscous polysaccharide enriched biscuitsDietary supplement
Also called HVP
10 g of highly viscous polysaccharide
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Healthy subjects Receives: Dietary Supplement: Highly viscous polysaccharide enriched biscuits |
| 2 | Experimental | Diabetic subjects Receives: Dietary Supplement: Highly viscous polysaccharide enriched biscuits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Index
Measured: Two months
Secondary outcomes (1)
Palatability
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2008 (estimated)
- Study startAug 1989
- Primary completionNov 1989
- Study completionNov 1989
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 Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Investigators
- David Jenkins, MD, PhD, DSc, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728143
- Sponsor's protocol ID
- 1_Jenkins
- Status last verified
- Aug 2008
- First submitted
- 1 Aug 2008
- Last updated
- 5 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Jovanovski E, Jenkins A, Dias AG, Peeva V, Sievenpiper J, Arnason JT, Rahelic D, Josse RG, Vuksan V. Effects of Korean red ginseng (Panax ginseng C.A. Mayer) and its isolated ginsenosides and polysaccharides on arterial stiffness in healthy individuals. Am J Hypertens. 2010 May;23(5):469-72. doi: 10.1038/ajh.2010.5. Epub 2010 Feb 4.
PubMed 20134405
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Trials of Low Glycemic Index Foods and Dietary Fiber in the Management of Diabetes, Hyperlipidemia and Renal Disease
- ClinicalTrials.gov ID
- NCT00728143
- Acronym / sponsor ID
- 1_Jenkins
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Aug 1989
- Primary completion
- Nov 1989 (actual)
- Study completion
- Nov 1989 (actual)
- First posted
- 5 Aug 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.
Our objective was to test whether the highly viscous polysaccharide incorporated into the biscuit formulation would reduce the postprandial blood glucose response equally in healthy subjects and individuals with type 2 diabetes.
Detailed description
Despite significant achievements in treatment modalities and preventive measures, diabetes has been increasing exponentially. Reduction in both fasting and prolonged postprandial glycemia is of paramount importance in the disease prevention and the delay of diabetic complications. Blood glucose concentration can be reduced by dietary means, and may be influenced by factors such as type and amount of carbohydrate, nature of starch, quantity of protein and fat, dietary fiber content, method of food processing, particle size and food form. Glycemic index (GI) is a measure of the blood glucose-raising ability of the available carbohydrate in foods. Although evidence is often insufficient and individual differences occur, prospective studies and clinical trials have shown that low-GI diets may reduce the risk of diabetes and improve glycemic control in diabetes.
High postprandial plasma glucose level can increase severity of diabetes and foods which raise the blood glucose level least for a given carbohydrate content are most suitable for individuals with type 2 diabetes. Lower postprandial glycemia is also important for healthy subjects to prevent diabetes.
High fiber diets have been recommended for the general population and for the nutritional management of patients with type 2 diabetes. Soluble dietary fiber retards digestion and absorption of the associated dietary carbohydrate, thus flattening the postprandial rise in plasma glucose and insulin concentrations. Some foods such as beta-glucan fiber containing oats and barley, and soluble fibers isolates such as pectin, guar, psyllium, or glucomannan have a high viscosity which gives them the greatest blood glucose lowering effect. Viscous fibers, as a result of their rheological properties, form gel with the food and human digesta and consequently reduce postprandial increases in plasma glucose concentrations in both normal and diabetic subjects in positive relation to their level of viscosity. Insoluble fibers such as cellulose and wheat bran have little effect.
The highly viscous polysaccharide (HVP) added to the study biscuit formulation is a blend of highly viscous soluble fibers (polysaccharides) that act synergistically to develop a higher level of viscosity than any other known dietary fiber in nature. One of the main components of the HVP is glucomannan, a glucose-mannose polysaccharide obtained from grinding the tuber root of Amorphophallus Konjac C. Koch, a plant that has been used as food and remedy for thousands of years in the Far East. Highly refined glucomannan is 3 times more viscous than guar and approximately 7 times more viscous than psyllium. The viscosity of the HVP is amplified further with a viscosity 3-5 times higher than glucomannan alone used in formulation, that is considered to be the highest viscosity single dietary fiber. Previously we and others have shown that the higher viscosity in vitro directly corresponded to lower blood glucose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Highly viscous polysaccharide enriched biscuitsHealthy subjects |
| 2 | Experimental | Dietary Supplement: Highly viscous polysaccharide enriched biscuitsDiabetic subjects |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- males or non-pregnant females aged 18-75 years and in good health;
- BMI <30 kg/m2.
- documented type 2 diabetes for at least 6 month duration without clinically manifest complications;
- age 18-75 years;
- BMI <30 kg/m2.
Key exclusion criteria (9 listed)
- known history of hepatitis, diabetes or a heart condition;
- using medications or fiber supplements;
- any health condition which might affect the results;
- non-compliance with the experimental procedures.
- liver or kidney disease;
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 |
|---|---|---|
| Highly viscous polysaccharide enriched biscuitsAlso: HVP10 g of highly viscous polysaccharide | Dietary supplement | 1, 2 |
Primary outcome
Glycemic Index
Time frame: Two months
1 secondary outcome
Palatability
Time frame: Two months
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 5 Aug 2008.
- Derived from this study: PubMed 20134405Jovanovski E, Jenkins A, Dias AG, Peeva V, Sievenpiper J, Arnason JT, Rahelic D, Josse RG, Vuksan V. Effects of Korean red ginseng (Panax ginseng C.A. Mayer) and its isolated ginsenosides and polysaccharides on arterial stiffness in healthy individuals. Am J Hypertens. 2010 May;23(5):469-72. doi: 10.1038/ajh.2010.5. Epub 2010 Feb 4.
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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.
David Jenkins, MD, PhD, DSc principal investigator
Unity Health Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Highly viscous polysaccharide enriched biscuits in people with Type 2 Diabetes, run by Unity Health Toronto.
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 9 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 5 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Glycemic Index (time frame: Two months). 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 NCT00728143, 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 5 Aug 2008.