Effect of Replacing HFCS With Sucromalt in Subjects With Raised Waist Circumference
Condition: Abdominal Obesity
MeSH terms: Obesity, Abdominal
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): High Fructose Corn Syrup; Sucromalt
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Carbohydrate; Glycemic index; Randomized; Double-blind; Glucose; Insulin; C-reactive protein