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CompletedNCT00728143Updated Aug 5, 2008

Blood Glucose Response to Highly Viscous Polysaccharide Enriched Biscuits in Healthy and Diabetic Subjects

An interventional study of Highly viscous polysaccharide enriched biscuits in Type 2 Diabetes, sponsored by Unity Health Toronto. Completed. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-08-05.

Sponsored by Unity Health Toronto · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Type 2 Diabetes
03

In context

Lead sponsor

Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria (arm 1):

  • males or non-pregnant females aged 18-75 years and in good health;
  • BMI \<30 kg/m2.

Exclusion Criteria (arm 1):

  • 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.

Inclusion Criteria (arm 2):

  • documented type 2 diabetes for at least 6 month duration without clinically manifest complications;
  • age 18-75 years;
  • BMI \<30 kg/m2.

Exclusion Criteria (arm 2):

  • liver or kidney disease;
  • gastrointestinal problems;
  • using fiber supplements;
  • non-compliance with the experimental procedures;
  • pregnancy.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
19 participants (actual)

Study arms

  • Active comparator
    1

    Healthy subjects

    Dietary Supplement: Highly viscous polysaccharide enriched biscuits

  • Experimental
    2

    Diabetic subjects

    Dietary Supplement: Highly viscous polysaccharide enriched biscuits

Interventions

  • Dietary supplementHighly viscous polysaccharide enriched biscuits

    10 g of highly viscous polysaccharide

    Also known as: HVP

06

What researchers measure

Primary outcomes

  1. Glycemic Index

    Time frame: Two months

Secondary outcomes

  1. Palatability

    Time frame: Two months

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00728143
Lead sponsor
Unity Health Toronto
First posted
Aug 5, 2008
Start date
Aug 1989
Primary completion
Nov 1989
Completion
Nov 1989
Last update
Aug 5, 2008

Study contacts

David Jenkins, MD, PhD, DSc
principal investigator · Unity Health Toronto

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

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