Abdominal Obesity Clinical Trial
Official title:
Effect of Replacing HFCS With Sucromalt on Glucose Tolerance, Blood Lipids and Inflammatory Markers in Subjects With Raised Waist Circumference
Weight gain is linked to a high consumption of soft-drinks and other beverages sweetened with high fructose corn syrup. Being overweight increases risk for diabetes and heart disease. These problems may be due to high blood glucose and insulin responses caused by high fructose corn syrup. Sucromalt is a sweetener which contains the same amount of carbohydrate at high fructose corn syrup, but causes lower glucose and insulin responses. The purpose of this study is to see if consuming soft-drinks and other foods sweetened with sucromalt instead of high fructose corn syrup will result in lower levels of blood glucose, insulin, cholesterol and other markers of risk. We are including in this study people who are overweight and normally consume soft-drinks because they are the ones most likely to benefit from this change.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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