ObesityNCT02702479
Meta-analyses of the Effect of Sucrose Versus High Fructose Corn Syrup on Cardiometabolic Risk
An observational study of Obesity and Dyslipidemia, run by University of Toronto at 1 site in Canada.
Trial summary
The rise in high fructose corn syrup (HFCS) consumption over the past 40 years since its introduction as a popular sweetener in the United States has led to much concern regarding its contribution to the rise in obesity (1), diabetes (2) and related cardiometabolic disorders (3).Unlike sucrose which contains equal… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obesity, Dyslipidemia, Prediabetes
- What is being tested?
- High Fructose Corn Syrup and Sucrose
- Type of treatment
- Pill or oral medicine
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Jun 2016
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All individuals, both children and adults, regardless of health status.
Who may be able to join
- Trials in humans
- Oral fructose-containing sugars intervention
- Presence of an adequate comparator in isocaloric substitution
- Diet duration >=7 days
- Viable outcome data
Who cannot join
- Non-human trials
- Observational studies
- IV or parenteral fructose-containing sugars
- Lack of suitable comparator (i.e. a comparator arm not including sucrose or HFCS in isocaloric substitution)
- Diet duration <7 days
- No viable outcome data
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Toronto 3D (Diet, Digestive tract and Disease) Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, M5C 2T2
About this study
Official title: Effect of Sucrose Versus High Fructose Corn Syrup on Cardiometabolic Risk: A Series of Systematic Reviews and Meta-Analyses of Controlled Trials
The rise in high fructose corn syrup (HFCS) consumption over the past 40 years since its introduction as a popular sweetener in the United States has led to much concern regarding its contribution to the rise in obesity (1), diabetes (2) and related cardiometabolic disorders (3).Unlike sucrose which contains equal proportions of fructose and glucose bound by an α-glycosidic bond, HFCS contains 42-55% of fructose to glucose in a free (unbound) form (4). Despite these differences in composition, both sugars possess identical energy contribution on a gram to gram basis (4). However, the higher ratio of fructose to glucose in HFCS has led to the hypothesis that HFCS may uniquely contribute to cardiometabolic risk, more so than sucrose, through proposed differences in fructose metabolism, endocrine and hedonic properties (5). We will conduct a series of systematic reviews and meta-analyses to assess the role of HFCS versus sucrose under energy matched (isocaloric) conditions on cardiometabolic risk.
Read the detailed description
Need for proposed research: High quality systematic reviews and meta-analyses of controlled trials represent the highest level of evidence to support dietary guidelines and public health policy development. As HFCS has gained increasing popularity as a popular sweetener over the past ~50 years, replacing sucrose in the diet, there is an urgent need for systematic reviews and meta-analyses comparing sucrose versus HFCS in the development of cardiometaboilc diseases.
Objective: The investigators will conduct a series systematic reviews and meta-analyses to distinguish the effect of isocaloric exchange of sucrose versus HFCS on cardiometabolic risk in controlled trials.
Design: Each systematic review and meta-analysis will be conducted according to the Cochrane Handbook for Systematic Reviews of Interventions and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).
Data sources: MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials (Clinical Trials; CENTRAL) will be searched using appropriate search terms supplemented by hand searches of references of included studies.
Study selection: The investigators will include randomized and non-randomized controlled trials >= 7-days in duration to assess the effect of sucrose versus HFCS under isocaloric conditions on measures of cardiometabolic risk. Direct comparisons of sucrose versus HFCS and indirect comparisons of sucrose or HFCS versus other carbohydrates under energy-matched conditions will be conducted.
Data extraction: Two or more investigators will independently extract relevant data and assess risk of bias using the Cochrane Risk of Bias Tool. All disagreements will be resolved by consensus. Standard computations and imputations will be used to derive missing variance data.
Outcomes: Seven sets of outcomes will be assessed: (1) body weight and markers of adipsoity (2) glycemic control, (3) blood pressure, (4) blood lipids, (5) uric acid, (6) non-alcoholic fatty liver disease (NAFLD) and ectopic fat, (7) inflammation
Data synthesis: Mean differences will be pooled using the generic inverse variance method when data are available from more than 2 trials. Random-effects models will be used even in the absence of statistically significant between-study heterogeneity, as they yield more conservative summary effect estimates in the presence of residual heterogeneity. Fixed-effects models will only be used where there is <5 included studies. Paired analyses will be applied for crossover trials. Heterogeneity will be assessed by the Cochran Q statistic and quantified by the I2 statistic. To explore sources of heterogeneity, the investigators will conduct sensitivity analyses, in which each study is systematically removed. If there are >=10 studies per endpoint, then the investigators will also explore sources of heterogeneity by a priori subgroup analyses by age (children [=<18 years of age], adults), health status (metabolic syndrome criteria, diabetes, overweight/ obese, healthy), comparator type, fructose- containing sugar form (sucrose, HFCS, honey, fructose), dose (=<10% energy, >10% energy), baseline measurements, randomization, study design (parallel, crossover), energy balance (positive, neutral, negative), follow-up (=<8-weeks, >8-weeks), and risk of bias. Meta-regression analyses will assess the significance of categorical and continuous subgroups analyses. When >=10 studies are available, publication bias will be investigated by inspection of funnel plots and formal testing using the Egger's and Begg's tests. If publication bias is suspected, then the investigators will attempt to adjust for funnel plot asymmetry by imputing the missing study data using the Duval and Tweedie trim and fill method.
Evidence Assessment: The strength of the evidence for each outcome will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE).
Knowledge translation plan: The results will be disseminated through interactive presentations at local, national, and international scientific meetings and publication in high impact factor journals. Target audiences will include the public health and scientific communities with interest in nutrition, diabetes, obesity, and cardiovascular disease. Feedback will be incorporated and used to improve the public health message and key areas for future research will be defined. Applicant/Co-applicant Decision Makers will network among opinion leaders to increase awareness and participate directly as committee members in the development of future guidelines.
Significance: The proposed project will aid in knowledge translation related to the role of sucrose versus HFCS in the development of cardiometabolic diseases, strengthening the evidence-base for guidelines and improving health outcomes by educating healthcare providers and patients, stimulating industry innovation, and guiding future research design.
- Conditions
- Obesity, Dyslipidemia, Prediabetes, Dysglycemia, Gout, Hypertension
- Being tested
- High Fructose Corn Syrup, Sucrose
- Keywords
- Systematic review and meta-analysis, Evidence-based medicine (EBM), Evidence-based nutrition (EBN), Clinical practice guidelines, Clinical trials, Dietary sugars, Fructose, High fructose corn syrup, Isocaloric, Hypercaloric, Cardiometabolic Risk Factors, Triglycerides, Cholesterol, Glycemic control, Body weight, Uric acid, Blood pressure, Fatty liver, Fasting, Postprandial
- Medical subject headings
- Obesity, Dyslipidemias, Prediabetic State, Gout, Hypertension, Non-alcoholic Fatty Liver Disease, Cardiovascular Diseases, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Fructose Corn SyrupOther
Also called HFCS
An intervention in which calories from HFCS are substituted isocalorically for sucrose in the diet
SucroseOther
Also called sugar
An intervention in which calories from sucrose are substituted isocalorically for HFCS in the diet
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight and measures of adiposity analysis
Measured: Up to 20 years
Glycemic control analysis
Measured: Up to 20 years
Blood Lipids analysis
Measured: Up to 20 years
Blood pressure analysis
Measured: Up to 20 years
Uric acid analysis
Measured: Up to 20 years
Non-Alcoholic Fatty Liver Disease (NAFLD) and ectopic fat Analysis
Measured: Up to 20 years
Inflammation analysis
Measured: Up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startJun 2014
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Physicians' Services Incorporated Foundation, Banting & Best Diabetes Centre
- Responsible party
- Principal investigator, John Sievenpiper, University of Toronto
- Investigators
- John L Sievenpiper, MD,PhD,FRCPC, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702479
- Sponsor's protocol ID
- CIHR-Surose vs HFCS
- Status last verified
- May 2016
- First submitted
- 2 Mar 2016
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sucrose Versus High Fructose Corn Syrup on Cardiometabolic Risk: A Series of Systematic Reviews and Meta-Analyses of Controlled Trials
- ClinicalTrials.gov ID
- NCT02702479
- Acronym / sponsor ID
- CIHR-Surose vs HFCS
- Conditions
- Obesity, Dyslipidemia, Prediabetes, Dysglycemia, Gout, Hypertension
- Keywords
- Systematic review and meta-analysis, Evidence-based medicine (EBM), Evidence-based nutrition (EBN), Clinical practice guidelines, Clinical trials, Dietary sugars, Fructose, High fructose corn syrup
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Physicians' Services Incorporated Foundation, Banting & Best Diabetes Centre
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 8 Mar 2016 (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.
The rise in high fructose corn syrup (HFCS) consumption over the past 40 years since its introduction as a popular sweetener in the United States has led to much concern regarding its contribution to the rise in obesity (1), diabetes (2) and related cardiometabolic disorders (3).Unlike sucrose which contains equal proportions of fructose and glucose bound by an α-glycosidic bond, HFCS contains 42-55% of fructose to glucose in a free (unbound) form (4). Despite these differences in composition, both sugars possess identical energy contribution on a gram to gram basis (4). However, the higher ratio of fructose to glucose in HFCS has led to the hypothesis that HFCS may uniquely contribute to cardiometabolic risk, more so than sucrose, through proposed differences in fructose metabolism, endocrine and hedonic properties (5). We will conduct a series of systematic reviews and meta-analyses to assess the role of HFCS versus sucrose under energy matched (isocaloric) conditions on cardiometabolic risk.
Detailed description
Need for proposed research: High quality systematic reviews and meta-analyses of controlled trials represent the highest level of evidence to support dietary guidelines and public health policy development. As HFCS has gained increasing popularity as a popular sweetener over the past ~50 years, replacing sucrose in the diet, there is an urgent need for systematic reviews and meta-analyses comparing sucrose versus HFCS in the development of cardiometaboilc diseases.
Objective: The investigators will conduct a series systematic reviews and meta-analyses to distinguish the effect of isocaloric exchange of sucrose versus HFCS on cardiometabolic risk in controlled trials.
Design: Each systematic review and meta-analysis will be conducted according to the Cochrane Handbook for Systematic Reviews of Interventions and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).
Data sources: MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials (Clinical Trials; CENTRAL) will be searched using appropriate search terms supplemented by hand searches of references of included studies.
Study selection: The investigators will include randomized and non-randomized controlled trials >= 7-days in duration to assess the effect of sucrose versus HFCS under isocaloric conditions on measures of cardiometabolic risk. Direct comparisons of sucrose versus HFCS and indirect comparisons of sucrose or HFCS versus other carbohydrates under energy-matched conditions will be conducted.
Data extraction: Two or more investigators will independently extract relevant data and assess risk of bias using the Cochrane Risk of Bias Tool. All disagreements will be resolved by consensus. Standard computations and imputations will be used to derive missing variance data.
Outcomes: Seven sets of outcomes will be assessed: (1) body weight and markers of adipsoity (2) glycemic control, (3) blood pressure, (4) blood lipids, (5) uric acid, (6) non-alcoholic fatty liver disease (NAFLD) and ectopic fat, (7) inflammation
Data synthesis: Mean differences will be pooled using the generic inverse variance method when data are available from more than 2 trials. Random-effects models will be used even in the absence of statistically significant between-study heterogeneity, as they yield more conservative summary effect estimates in the presence of residual heterogeneity. Fixed-effects models will only be used where there is <5 included studies. Paired analyses will be applied for crossover trials. Heterogeneity will be assessed by the Cochran Q statistic and quantified by the I2 statistic. To explore sources of heterogeneity, the investigators will conduct sensitivity analyses, in which each study is systematically removed. If there are >=10 studies per endpoint, then the investigators will also explore sources of heterogeneity by a priori subgroup analyses by age (children [=<18 years of age], adults), health status (metabolic syndrome criteria, diabetes, overweight/ obese, healthy), comparator type, fructose- containing sugar form (sucrose, HFCS, honey, fructose), dose (=<10% energy, >10% energy), baseline measurements, randomization, study design (parallel, crossover), energy balance (positive, neutral, negative), follow-up (=<8-weeks, >8-weeks), and risk of bias. Meta-regression analyses will assess the significance of categorical and continuous subgroups analyses. When >=10 studies are available, publication bias will be investigated by inspection of funnel plots and formal testing using the Egger's and Begg's tests. If publication bias is suspected, then the investigators will attempt to adjust for funnel plot asymmetry by imputing the missing study data using the Duval and Tweedie trim and fill method.
Evidence Assessment: The strength of the evidence for each outcome will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE).
Knowledge translation plan: The results will be disseminated through interactive presentations at local, national, and international scientific meetings and publication in high impact factor journals. Target audiences will include the public health and scientific communities with interest in nutrition, diabetes, obesity, and cardiovascular disease. Feedback will be incorporated and used to improve the public health message and key areas for future research will be defined. Applicant/Co-applicant Decision Makers will network among opinion leaders to increase awareness and participate directly as committee members in the development of future guidelines.
Significance: The proposed project will aid in knowledge translation related to the role of sucrose versus HFCS in the development of cardiometabolic diseases, strengthening the evidence-base for guidelines and improving health outcomes by educating healthcare providers and patients, stimulating industry innovation, and guiding future research design.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All individuals, both children and adults, regardless of health status.
Key inclusion criteria (5 listed)
- Trials in humans
- Oral fructose-containing sugars intervention
- Presence of an adequate comparator in isocaloric substitution
- Diet duration >=7 days
- Viable outcome data
Key exclusion criteria (6 listed)
- Non-human trials
- Observational studies
- IV or parenteral fructose-containing sugars
- Lack of suitable comparator (i.e. a comparator arm not including sucrose or HFCS in isocaloric substitution)
- Diet duration <7 days
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 SyrupAlso: HFCSAn intervention in which calories from HFCS are substituted isocalorically for sucrose in the diet | Other | – |
| SucroseAlso: sugarAn intervention in which calories from sucrose are substituted isocalorically for HFCS in the diet | Other | – |
Primary outcome
Body weight and measures of adiposity analysis
Time frame: Up to 20 years
Glycemic control analysis
Time frame: Up to 20 years
Blood Lipids analysis
Time frame: Up to 20 years
Blood pressure analysis
Time frame: Up to 20 years
Uric acid analysis
Time frame: Up to 20 years
Non-Alcoholic Fatty Liver Disease (NAFLD) and ectopic fat Analysis
Time frame: Up to 20 years
Inflammation analysis
Time frame: Up to 20 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
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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.
John L Sievenpiper, MD,PhD,FRCPC 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?
An observational study of Obesity and Dyslipidemia, 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 17 May 2016. 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.
Are results available for this study?
Results are not available in the source record.
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?
Body weight and measures of adiposity analysis (time frame: Up to 20 years). The study lists 7 primary outcomes in all. 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 17 May 2016.