Abdominal ObesityPhase 2NCT00374218
Effect of Replacing HFCS With Sucromalt in Subjects With Raised Waist Circumference
A Phase 2 study testing High Fructose Corn Syrup and Sucromalt in people with Abdominal Obesity, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Obesity
- What is being tested?
- High Fructose Corn Syrup and Sucromalt
- Type of treatment
- Pill or oral medicine
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to Apr 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Replacing HFCS With Sucromalt on Glucose Tolerance, Blood Lipids and Inflammatory Markers in Subjects With Raised Waist Circumference
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.
Read the 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.
- Conditions
- Abdominal Obesity
- Being tested
- High Fructose Corn Syrup, Sucromalt
- Keywords
- Carbohydrate, Glycemic index, Randomized, Double-blind, Glucose, Insulin, C-reactive protein
- Medical subject headings
- Obesity, Abdominal, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Fructose Corn SyrupDrug
SucromaltDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting and 2h glucose after 75g oral glucose tolerance test
Measured: 4 weeks
Secondary outcomes (10)
Fasting and 2h insulin after 75g oral glucose
Measured: 4 weeks
Gut hormone responses (eg. GLP-1) after 75g oral glucose
Measured: 4 weeks
Postprandial glucose and insulin elicited by control and test foods/drinks
Measured: Baseline
Fasting blood lipids (total, HDL and LDL cholesterol and triglycerides)
Measured: Baseline and 4 weeks
Fasting C-reactive protein
Measured: Baseline and 4 weeks
Fasting apolipoproteins A1 and B100
Measured: Baseline and 4 weeks
Body weight
Measured: Weekly for 4 weeks
Waist circumference
Measured: 4 weeks
Blood pressure
Measured: 4 weeks
Symptoms
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2006 (estimated)
- Study startSep 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal ObesityStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Thomas MS Wolever, MD, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374218
- Sponsor's protocol ID
- UTREB17491
- Status last verified
- Aug 2007
- First submitted
- 8 Sep 2006
- Last updated
- 14 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Replacing HFCS With Sucromalt on Glucose Tolerance, Blood Lipids and Inflammatory Markers in Subjects With Raised Waist Circumference
- ClinicalTrials.gov ID
- NCT00374218
- Acronym / sponsor ID
- UTREB17491
- Conditions
- Abdominal Obesity
- Keywords
- Carbohydrate, Glycemic index, Randomized, Double-blind, Glucose, Insulin, C-reactive protein
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 11 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Fructose Corn Syrup | Drug | – |
| Sucromalt | Drug | – |
Primary outcome
Fasting and 2h glucose after 75g oral glucose tolerance test
Time frame: 4 weeks
10 secondary outcomes
Fasting and 2h insulin after 75g oral glucose
Time frame: 4 weeks
Gut hormone responses (eg. GLP-1) after 75g oral glucose
Time frame: 4 weeks
Postprandial glucose and insulin elicited by control and test foods/drinks
Time frame: Baseline
Fasting blood lipids (total, HDL and LDL cholesterol and triglycerides)
Time frame: Baseline and 4 weeks
Fasting C-reactive protein
Time frame: Baseline and 4 weeks
Fasting apolipoproteins A1 and B100
Time frame: Baseline and 4 weeks
Body weight
Time frame: Weekly for 4 weeks
Waist circumference
Time frame: 4 weeks
Blood pressure
Time frame: 4 weeks
Symptoms
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas MS Wolever, MD, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High Fructose Corn Syrup and Sucromalt in people with Abdominal Obesity, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting and 2h glucose after 75g oral glucose tolerance test (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2007; AzTrials last refreshed its copy on 7 Nov 2026.