Meta-analyses of Fructose-containing Sugars and Incident Cardiometabolic Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Calorie Control Council
Canada Research Chairs Endowment of the Federal Government of Canada
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
John Sievenpiper, University of Toronto
ClinicalTrials.gov Identifier:
NCT01608620
First received: May 28, 2012
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

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.


Condition
Overweight
Obesity
Dyslipidemia
Hyperlipidemia
Diabetes
Prediabetes
Dysglycemia
Gout
Hypertension
Metabolic Syndrome
Coronary Heart Disease
Cardiovascular Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Relation of Fructose-containing Sugars to Incident Cardiometabolic Disease: Systematic Reviews and Meta-analyses of Prospective Observational Studies to Provide Evidence-based Guidance for Nutrition Guidelines Development

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Overweight/obesity analysis [ Time Frame: up to 1.5-years ] [ Designated as safety issue: No ]
    Risk ratios for incident Overweight and obesity by total fructose-containing sugar exposure

  • Diabetes/metabolic syndrome analysis [ Time Frame: Up to 1.5-years ] [ Designated as safety issue: No ]
    Risk ratios for incident diabetes and metabolic syndrome by total fructose-containing sugar exposure

  • Hypertension analsysis [ Time Frame: Up to 1.5-years ] [ Designated as safety issue: No ]
    Risk ratios for incident hypertension by total fructose-containing sugar exposure

  • Gout analysis [ Time Frame: Up to 1.5-years ] [ Designated as safety issue: No ]
    Risk ratios for incident gout by total fructose-containing sugar exposure

  • Coronary heart disease (CHD) analysis [ Time Frame: Up to 1.5-years ] [ Designated as safety issue: No ]
    Risk ratios for incident CHD by total fructose-containing sugar exposure


Estimated Enrollment: 1
Study Start Date: May 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Varied

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608620

Locations
Canada, Ontario
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, Canada, M5C 2T2
Sponsors and Collaborators
John Sievenpiper
Calorie Control Council
Canada Research Chairs Endowment of the Federal Government of Canada
Canadian Institutes of Health Research (CIHR)
Investigators
Study Director: 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
Principal Investigator: 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
  More Information

Publications:

Responsible Party: John Sievenpiper, Adjunct Research Fellow, University of Toronto
ClinicalTrials.gov Identifier: NCT01608620     History of Changes
Other Study ID Numbers: CCC 2012 KRS EPI
Study First Received: May 28, 2012
Last Updated: July 2, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Toronto:
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
Fruit
Isocaloric
Hypercaloric
Cardiometabolic risk factors
Triglycerides
Cholesterol
Glycemic control
Insulin resistance
Body weight
Uric acid
Blood pressure

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Hyperlipidemias
Hypertension
Obesity
Dyslipidemias
Glucose Intolerance
Prediabetic State
Overweight
Metabolic Syndrome X
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Hyperglycemia
Glucose Metabolism Disorders
Diabetes Mellitus
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on August 19, 2014