Obesity Clinical Trial
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.
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.
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