NCT02702479

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

2 years

First QC Date

March 2, 2016

Last Update Submit

May 14, 2016

Conditions

Keywords

Systematic review and meta-analysisEvidence-based medicine (EBM)Evidence-based nutrition (EBN)Clinical practice guidelinesClinical trialsDietary sugarsFructoseHigh fructose corn syrupIsocaloricHypercaloricCardiometabolic Risk FactorsTriglyceridesCholesterolGlycemic controlBody weightUric acidBlood pressureFatty liverFastingPostprandial

Outcome Measures

Primary Outcomes (7)

  • Body weight and measures of adiposity analysis

    Up to 20 years

  • Glycemic control analysis

    Up to 20 years

  • Blood Lipids analysis

    Up to 20 years

  • Blood pressure analysis

    Up to 20 years

  • Uric acid analysis

    Up to 20 years

  • Non-Alcoholic Fatty Liver Disease (NAFLD) and ectopic fat Analysis

    Up to 20 years

  • Inflammation analysis

    Up to 20 years

Interventions

An intervention in which calories from HFCS are substituted isocalorically for sucrose in the diet

Also known as: HFCS
SucroseOTHER

An intervention in which calories from sucrose are substituted isocalorically for HFCS in the diet

Also known as: sugar

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All individuals, both children and adults, regardless of health status.

You may qualify if:

  • Trials in humans
  • Oral fructose-containing sugars intervention
  • Presence of an adequate comparator in isocaloric substitution
  • Diet duration \>=7 days
  • Viable outcome data

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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, Canada

Location

MeSH Terms

Conditions

ObesityDyslipidemiasPrediabetic StateGoutHypertensionNon-alcoholic Fatty Liver DiseaseCardiovascular DiseasesBody WeightFatty LiverFasting

Interventions

High Fructose Corn SyrupSucroseSugars

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLipid Metabolism DisordersMetabolic DiseasesDiabetes MellitusGlucose Metabolism DisordersEndocrine System DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesVascular DiseasesLiver DiseasesDigestive System DiseasesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Dietary SugarsDietary CarbohydratesCarbohydratesNutritive SweetenersSweetening AgentsFlavoring AgentsFood AdditivesFood IngredientsSpecialty Uses of ChemicalsChemical Actions and UsesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesDisaccharidesOligosaccharidesPolysaccharides

Study Officials

  • John L Sievenpiper, MD,PhD,FRCPC

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 8, 2016

Study Start

June 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations