Status:
COMPLETED
Effect of Replacing HFCS With Sucromalt in Subjects With Raised Waist Circumference
Lead Sponsor:
University of Toronto
Conditions:
Abdominal Obesity
Eligibility:
All Genders
20-50 years
Phase:
PHASE2
Brief 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 m...
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 incr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00374218
Start Date
September 1 2006
End Date
April 1 2007
Last Update
August 14 2007
Active Locations (1)
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1
Glycemic Index Laboratories
Toronto, Ontario, Canada, M5C 2X3