Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00728143
First received: August 1, 2008
Last updated: August 4, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Dietary Supplement: Highly viscous polysaccharide enriched biscuits

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Therapeutic Trials of Low Glycemic Index Foods and Dietary Fiber in the Management of Diabetes, Hyperlipidemia and Renal Disease

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Glycemic Index [ Time Frame: Two months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Palatability [ Time Frame: Two months ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: August 1989
Study Completion Date: November 1989
Primary Completion Date: November 1989 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Healthy subjects
Dietary Supplement: Highly viscous polysaccharide enriched biscuits
10 g of highly viscous polysaccharide
Other Name: HVP
Experimental: 2
Diabetic subjects
Dietary Supplement: Highly viscous polysaccharide enriched biscuits
10 g of highly viscous polysaccharide
Other Name: HVP

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728143

Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: David Jenkins, MD, PhD, DSc St. Michael's Hospital, Toronto
  More Information

No publications provided by St. Michael's Hospital, Toronto

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director of Research, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
ClinicalTrials.gov Identifier: NCT00728143     History of Changes
Other Study ID Numbers: 1_Jenkins
Study First Received: August 1, 2008
Last Updated: August 4, 2008
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 24, 2014