- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00374218
Effect of Replacing HFCS With Sucromalt in Subjects With Raised Waist Circumference
Effect of Replacing HFCS With Sucromalt on Glucose Tolerance, Blood Lipids and Inflammatory Markers in Subjects With Raised Waist Circumference
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5C 2X3
- Glycemic Index Laboratories
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fasting and 2h glucose after 75g oral glucose tolerance test
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood pressure
Time Frame: 4 weeks
|
4 weeks
|
Fasting and 2h insulin after 75g oral glucose
Time Frame: 4 weeks
|
4 weeks
|
Gut hormone responses (eg. GLP-1) after 75g oral glucose
Time Frame: 4 weeks
|
4 weeks
|
Postprandial glucose and insulin elicited by control and test foods/drinks
Time Frame: Baseline
|
Baseline
|
Fasting blood lipids (total, HDL and LDL cholesterol and triglycerides)
Time Frame: Baseline and 4 weeks
|
Baseline and 4 weeks
|
Fasting C-reactive protein
Time Frame: Baseline and 4 weeks
|
Baseline and 4 weeks
|
Fasting apolipoproteins A1 and B100
Time Frame: Baseline and 4 weeks
|
Baseline and 4 weeks
|
Body weight
Time Frame: Weekly for 4 weeks
|
Weekly for 4 weeks
|
Waist circumference
Time Frame: 4 weeks
|
4 weeks
|
Symptoms
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas MS Wolever, MD, PhD, University of Toronto
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UTREB17491
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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