Effect of Replacing HFCS With Sucromalt in Subjects With Raised Waist Circumference
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|ClinicalTrials.gov Identifier: NCT00374218|
Recruitment Status : Completed
First Posted : September 11, 2006
Last Update Posted : August 14, 2007
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Obesity||Drug: High Fructose Corn Syrup Drug: Sucromalt||Phase 2|
Diets with a high glycemic load (GL) are associated with increased risk of diabetes and cardiovascular disease, possibly because of their association with the metabolic syndrome, dyslipidemia and increased markers of chronic inflammation. Since GL is the product of glycemic index (GI) times the amount of carbohydrate in the diet, GL can be reduced either by reducing GI or by reducing carbohydrate intake, and the effect of these maneuvers on health biomarkers may not necessarily be the same.
A high consumption of sugars in regular soft drinks has been associated with increased weight gain in adolescents, and, in adults, replacing starch with sucrose in the diet has been shown to result in weight gain and an increase in blood pressure and certain inflammatory markers. However, in the latter studies, the effects of sucrose in sucrose-sweetened beverages and foods were compared to those of aspartame-sweetened beverages and foods. Since aspartame contains no energy, the sucrose and control diets differed not only in sucrose, but also in energy, fat and protein; with more energy and less fat and protein as a % of energy on the sucrose than the control diet. This results in a problem in interpretation of the results because it is not possible to know what dietary change was responsible for the changes in biomarkers - indeed some changes due to increased sucrose intake may have been offset by opposite changes in, for example, saturated fat intake.
Another approach to studying the effect of reducing the GL of the diet is to reduce the GI of the diet without changing the amounts of energy, carbohydrate, fat or protein. Such an approach may be more scientifically desirable because it is possible to study the effect of changing only one dietary variable. Recently, the development of sucromalt allows the replacement of high fructose corn syrup (HFCS) in foods and beverages with a nutritive carbohydrate sweetener that has a reduced GI. Sucromalt is an enzymatically modified carbohydrate which we have shown elicits lower glucose and insulin responses than HFCS without apparent malabsorption. Therefore, the purpose of this study is to conduct a pilot study to see if exchanging HFCS with sucromalt has any effect on glucose tolerance and fasting blood lipids and inflammatory biomarkers in subjects with a high waist circumference.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Effect of Replacing HFCS With Sucromalt on Glucose Tolerance, Blood Lipids and Inflammatory Markers in Subjects With Raised Waist Circumference|
|Study Start Date :||September 2006|
|Actual Study Completion Date :||April 2007|
- Fasting and 2h glucose after 75g oral glucose tolerance test [ Time Frame: 4 weeks ]
- Fasting and 2h insulin after 75g oral glucose [ Time Frame: 4 weeks ]
- Gut hormone responses (eg. GLP-1) after 75g oral glucose [ Time Frame: 4 weeks ]
- Postprandial glucose and insulin elicited by control and test foods/drinks [ Time Frame: Baseline ]
- Fasting blood lipids (total, HDL and LDL cholesterol and triglycerides) [ Time Frame: Baseline and 4 weeks ]
- Fasting C-reactive protein [ Time Frame: Baseline and 4 weeks ]
- Fasting apolipoproteins A1 and B100 [ Time Frame: Baseline and 4 weeks ]
- Body weight [ Time Frame: Weekly for 4 weeks ]
- Waist circumference [ Time Frame: 4 weeks ]
- Blood pressure [ Time Frame: 4 weeks ]
- Symptoms [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00374218
|Glycemic Index Laboratories|
|Toronto, Ontario, Canada, M5C 2X3|
|Principal Investigator:||Thomas MS Wolever, MD, PhD||University of Toronto|