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

Tracking Information
First Submitted Date ICMJE	August 1, 2008
First Posted Date ICMJE	August 5, 2008
Last Update Posted Date	August 5, 2008
Study Start Date ICMJE	August 1989
Actual Primary Completion Date	November 1989 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 4, 2008)	Glycemic Index [ Time Frame: Two months ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: August 4, 2008)	Palatability [ Time Frame: Two months ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Blood Glucose Response to Highly Viscous Polysaccharide Enriched Biscuits in Healthy and Diabetic Subjects
Official Title ICMJE	Therapeutic Trials of Low Glycemic Index Foods and Dietary Fiber in the Management of Diabetes, Hyperlipidemia and Renal Disease
Brief 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.
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 Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Prevention
Condition ICMJE	Type 2 Diabetes
Intervention ICMJE	Dietary Supplement: Highly viscous polysaccharide enriched biscuits; 10 g of highly viscous polysaccharide; Other Name: HVP
Study Arms	Active Comparator: 1 Healthy subjects Intervention: Dietary Supplement: Highly viscous polysaccharide enriched biscuits; Experimental: 2 Diabetic subjects Intervention: Dietary Supplement: Highly viscous polysaccharide enriched biscuits
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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: August 4, 2008)	19
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	November 1989
Actual Primary Completion Date	November 1989 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 75 Years (Adult, Older Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00728143
Other Study ID Numbers ICMJE	1_Jenkins
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Director of Research, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Study Sponsor ICMJE	St. Michael's Hospital, Toronto
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: David Jenkins, MD, PhD, DSc St. Michael's Hospital, Toronto
PRS Account	St. Michael's Hospital, Toronto
Verification Date	August 2008
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP