Effect of Replacing HFCS With Sucromalt in Subjects With Raised Waist Circumference
Primary Purpose
Abdominal Obesity
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
High Fructose Corn Syrup
Sucromalt
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Obesity focused on measuring Carbohydrate, Glycemic index, Randomized, Double-blind, Glucose, Insulin, C-reactive protein
Eligibility 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
Sites / Locations
- Glycemic Index Laboratories
Outcomes
Primary Outcome Measures
Fasting and 2h glucose after 75g oral glucose tolerance test
Secondary Outcome Measures
Fasting and 2h insulin after 75g oral glucose
Gut hormone responses (eg. GLP-1) after 75g oral glucose
Postprandial glucose and insulin elicited by control and test foods/drinks
Fasting blood lipids (total, HDL and LDL cholesterol and triglycerides)
Fasting C-reactive protein
Fasting apolipoproteins A1 and B100
Body weight
Waist circumference
Blood pressure
Symptoms
Full Information
NCT ID
NCT00374218
First Posted
September 8, 2006
Last Updated
August 13, 2007
Sponsor
University of Toronto
1. Study Identification
Unique Protocol Identification Number
NCT00374218
Brief Title
Effect of Replacing HFCS With Sucromalt in Subjects With Raised Waist Circumference
Official Title
Effect of Replacing HFCS With Sucromalt on Glucose Tolerance, Blood Lipids and Inflammatory Markers in Subjects With Raised Waist Circumference
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity
Keywords
Carbohydrate, Glycemic index, Randomized, Double-blind, Glucose, Insulin, C-reactive protein
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
High Fructose Corn Syrup
Intervention Type
Drug
Intervention Name(s)
Sucromalt
Primary Outcome Measure Information:
Title
Fasting and 2h glucose after 75g oral glucose tolerance test
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Fasting and 2h insulin after 75g oral glucose
Time Frame
4 weeks
Title
Gut hormone responses (eg. GLP-1) after 75g oral glucose
Time Frame
4 weeks
Title
Postprandial glucose and insulin elicited by control and test foods/drinks
Time Frame
Baseline
Title
Fasting blood lipids (total, HDL and LDL cholesterol and triglycerides)
Time Frame
Baseline and 4 weeks
Title
Fasting C-reactive protein
Time Frame
Baseline and 4 weeks
Title
Fasting apolipoproteins A1 and B100
Time Frame
Baseline and 4 weeks
Title
Body weight
Time Frame
Weekly for 4 weeks
Title
Waist circumference
Time Frame
4 weeks
Title
Blood pressure
Time Frame
4 weeks
Title
Symptoms
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas MS Wolever, MD, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glycemic Index Laboratories
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2X3
Country
Canada
12. IPD Sharing Statement
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Effect of Replacing HFCS With Sucromalt in Subjects With Raised Waist Circumference
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