NCT01608620

Brief Summary

Since uncontrolled observational studies first linked fructose to the epidemic of obesity almost a decade ago, it has become a focus of intense concern regarding its role in the obesity epidemic and increasing burden of cardiometabolic disease. Despite the uncertainties in the evidence, international health organizations have cautioned against moderate to high intakes fructose-containing sugars, especially those from sugar sweetened beverages (SSBs). To improve the evidence on which nutrition recommendations are based, the investigators propose to study of the role of fructose-containing sugars in the development of overweight/obesity, diabetes, hypertension, gout, and cardiovascular disease, by undertaking a series of systematic syntheses of the available prospective cohort studies. Prospective cohort studies have the advantage of relating "real world" intakes of sugars to clinically meaningful disease endpoints over long durations of follow-up. The findings generated by this proposed knowledge synthesis will help improve the health of consumers through informing recommendations for the general public, as well as those at risk of diabetes and cardiovascular disease.

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 May 2012

Longer than P75 for all trials

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

May 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 31, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

2.3 years

First QC Date

May 28, 2012

Last Update Submit

May 15, 2016

Conditions

Keywords

Systematic review and meta-analysisEvidence-based medicine (EBM)Evidence-based nutrition (EBN)Clinical practice guidelinesClinical trialsDietary sugarsFructoseHigh fructose corn syrupFruitIsocaloricHypercaloricCardiometabolic risk factorsTriglyceridesCholesterolGlycemic controlInsulin resistanceBody weightUric acidBlood pressure

Outcome Measures

Primary Outcomes (5)

  • Overweight/obesity analysis

    Risk ratios for incident Overweight and obesity by total fructose-containing sugar exposure

    up to 1.5-years

  • Diabetes/metabolic syndrome analysis

    Risk ratios for incident diabetes and metabolic syndrome by total fructose-containing sugar exposure

    Up to 1.5-years

  • Hypertension analsysis

    Risk ratios for incident hypertension by total fructose-containing sugar exposure

    Up to 1.5-years

  • Gout analysis

    Risk ratios for incident gout by total fructose-containing sugar exposure

    Up to 1.5-years

  • Coronary heart disease (CHD) analysis

    Risk ratios for incident CHD by total fructose-containing sugar exposure

    Up to 1.5-years

Eligibility Criteria

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

Varied

You may qualify if:

  • Prospective observational studies
  • Assessment of fructose-containing sugar exposure
  • Viable clinical outcome data by level of exposure

You may not qualify if:

  • Ecological, cross-sectional, and retrospective observational studies, clinical trials, and non-human studies
  • No assessment of fructose-containing sugar exposure
  • No viable clinical outcome data by level of exposure

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

Related Publications (12)

  • Sievenpiper JL, Carleton AJ, Chatha S, Jiang HY, de Souza RJ, Beyene J, Kendall CW, Jenkins DJ. Heterogeneous effects of fructose on blood lipids in individuals with type 2 diabetes: systematic review and meta-analysis of experimental trials in humans. Diabetes Care. 2009 Oct;32(10):1930-7. doi: 10.2337/dc09-0619. Epub 2009 Jul 10.

    PMID: 19592634BACKGROUND
  • Ha V, Sievenpiper JL, de Souza RJ, Chiavaroli L, Wang DD, Cozma AI, Mirrahimi A, Yu ME, Carleton AJ, Dibuono M, Jenkins AL, Leiter LA, Wolever TM, Beyene J, Kendall CW, Jenkins DJ. Effect of fructose on blood pressure: a systematic review and meta-analysis of controlled feeding trials. Hypertension. 2012 Apr;59(4):787-95. doi: 10.1161/HYPERTENSIONAHA.111.182311. Epub 2012 Feb 13.

    PMID: 22331380BACKGROUND
  • Sievenpiper JL, de Souza RJ, Mirrahimi A, Yu ME, Carleton AJ, Beyene J, Chiavaroli L, Di Buono M, Jenkins AL, Leiter LA, Wolever TM, Kendall CW, Jenkins DJ. Effect of fructose on body weight in controlled feeding trials: a systematic review and meta-analysis. Ann Intern Med. 2012 Feb 21;156(4):291-304. doi: 10.7326/0003-4819-156-4-201202210-00007.

    PMID: 22351714BACKGROUND
  • Wang DD, Sievenpiper JL, de Souza RJ, Chiavaroli L, Ha V, Cozma AI, Mirrahimi A, Yu ME, Carleton AJ, Di Buono M, Jenkins AL, Leiter LA, Wolever TM, Beyene J, Kendall CW, Jenkins DJ. The effects of fructose intake on serum uric acid vary among controlled dietary trials. J Nutr. 2012 May;142(5):916-23. doi: 10.3945/jn.111.151951. Epub 2012 Mar 28.

    PMID: 22457397BACKGROUND
  • Sievenpiper JL, Chiavaroli L, de Souza RJ, Mirrahimi A, Cozma AI, Ha V, Wang DD, Yu ME, Carleton AJ, Beyene J, Di Buono M, Jenkins AL, Leiter LA, Wolever TM, Kendall CW, Jenkins DJ. 'Catalytic' doses of fructose may benefit glycaemic control without harming cardiometabolic risk factors: a small meta-analysis of randomised controlled feeding trials. Br J Nutr. 2012 Aug;108(3):418-23. doi: 10.1017/S000711451200013X. Epub 2012 Feb 21.

    PMID: 22354959BACKGROUND
  • Sievenpiper JL, de Souza RJ, Jenkins DJ. Sugar: fruit fructose is still healthy. Nature. 2012 Feb 22;482(7386):470. doi: 10.1038/482470e. No abstract available.

    PMID: 22358823BACKGROUND
  • Sievenpiper JL, de Souza RJ, Kendall CW, Jenkins DJ. Is fructose a story of mice but not men? J Am Diet Assoc. 2011 Feb;111(2):219-20; author reply 220-2. doi: 10.1016/j.jada.2010.12.001. No abstract available.

    PMID: 21272692BACKGROUND
  • Jayalath VH, Sievenpiper JL, de Souza RJ, Ha V, Mirrahimi A, Santaren ID, Blanco Mejia S, Di Buono M, Jenkins AL, Leiter LA, Wolever TM, Beyene J, Kendall CW, Jenkins DJ. Total fructose intake and risk of hypertension: a systematic review and meta-analysis of prospective cohorts. J Am Coll Nutr. 2014;33(4):328-39. doi: 10.1080/07315724.2014.916237. Epub 2014 Aug 21.

  • Khan TA, Tayyiba M, Agarwal A, Mejia SB, de Souza RJ, Wolever TMS, Leiter LA, Kendall CWC, Jenkins DJA, Sievenpiper JL. Relation of Total Sugars, Sucrose, Fructose, and Added Sugars With the Risk of Cardiovascular Disease: A Systematic Review and Dose-Response Meta-analysis of Prospective Cohort Studies. Mayo Clin Proc. 2019 Dec;94(12):2399-2414. doi: 10.1016/j.mayocp.2019.05.034.

  • Tsilas CS, de Souza RJ, Mejia SB, Mirrahimi A, Cozma AI, Jayalath VH, Ha V, Tawfik R, Di Buono M, Jenkins AL, Leiter LA, Wolever TMS, Beyene J, Khan T, Kendall CWC, Jenkins DJA, Sievenpiper JL. Relation of total sugars, fructose and sucrose with incident type 2 diabetes: a systematic review and meta-analysis of prospective cohort studies. CMAJ. 2017 May 23;189(20):E711-E720. doi: 10.1503/cmaj.160706.

  • Jamnik J, Rehman S, Blanco Mejia S, de Souza RJ, Khan TA, Leiter LA, Wolever TM, Kendall CW, Jenkins DJ, Sievenpiper JL. Fructose intake and risk of gout and hyperuricemia: a systematic review and meta-analysis of prospective cohort studies. BMJ Open. 2016 Oct 3;6(10):e013191. doi: 10.1136/bmjopen-2016-013191.

  • Jayalath VH, de Souza RJ, Ha V, Mirrahimi A, Blanco-Mejia S, Di Buono M, Jenkins AL, Leiter LA, Wolever TM, Beyene J, Kendall CW, Jenkins DJ, Sievenpiper JL. Sugar-sweetened beverage consumption and incident hypertension: a systematic review and meta-analysis of prospective cohorts. Am J Clin Nutr. 2015 Oct;102(4):914-21. doi: 10.3945/ajcn.115.107243. Epub 2015 Aug 12.

MeSH Terms

Conditions

OverweightObesityDyslipidemiasHyperlipidemiasDiabetes MellitusPrediabetic StateGoutHypertensionMetabolic SyndromeCoronary DiseaseCardiovascular DiseasesInsulin ResistanceBody Weight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLipid Metabolism DisordersMetabolic DiseasesGlucose Metabolism DisordersEndocrine System DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesVascular DiseasesHyperinsulinismMyocardial IschemiaHeart Diseases

Study Officials

  • John L Sievenpiper, MD, PhD

    Department of Pathology and Molecular Medicine, McMaster University and Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital

    STUDY DIRECTOR
  • Russell J de Souza, ScD, RD

    Department of Epidemiology and Biostatistics, McMaster University and Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital

    STUDY DIRECTOR
  • David JA Jenkins, MD, PhD, DSc

    Department of Nutritional Sciences and Medicine, University of Toronto and Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Adjunct Research Fellow

Study Record Dates

First Submitted

May 28, 2012

First Posted

May 31, 2012

Study Start

May 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2016

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations