Effect of Replacing HFCS With Sucromalt in Subjects With Raised Waist Circumference

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Toronto

Criteria

Inclusion Criteria:

• males or non-pregnant and non-lactating females

• aged 20-50

• normally drink at least 2 cans (680ml) regular soft-drinks or sugar sweetened drinks per day

• high waist circumference (≥102cm (40in) in men or ≥88cm (34.5in) in women)

Exclusion Criteria:

• Body mass index >35.0kg/m²

• Subjects whose weight is not stable (varied by >5% of current weight over the past 6 months).

• Subject who regularly undertake >30min vigorous physical activity per week.

• Diabetes based on current treatment with insulin or an oral hypoglycemic agent or fasting glucose ≥7.0mmol/L on screening

• Fasting triglycerides ≥10.0mmol/L

• Severe liver dysfunction (transaminase >180% of upper limit of normal)

• Severe renal impairment (serum creatinine >140% of upper limit of normal)

• Any major medical or surgical event within 6 months

• History of inflammatory bowel disease, malabsorption, or other disorder or drug use affecting gastrointestinal motility or the absorption of nutrients

• Use of drugs which affect glucose or lipids except: stable doses (3 months) of statins, fibrates, beta-blockers, diuretics.

• Substance abuse

• Simultaneous participation in another clinical trial

• Any other condition which, in the opinion of Dr. Wolever, might make the subject's participating harmful to him(her)self or others or affect the results

• Inability to understand spoken and written English

• Unwilling or unable to consume the test foods (drinks and nutrition bars) and/or to undergo the test procedures

• Unwilling or unable to give informed consent and/or sign the consent form