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Trial record 1 of 1 for:    NCT01363791
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Meta-analyses of Fructose and Cardiometabolic Risk

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ClinicalTrials.gov Identifier: NCT01363791
Recruitment Status : Unknown
Verified May 2015 by John Sievenpiper, University of Toronto.
Recruitment status was:  Active, not recruiting
First Posted : June 2, 2011
Last Update Posted : May 27, 2015
Canadian Institutes of Health Research (CIHR)
Canada Research Chairs Endowment of the Federal Government of Canada
Calorie Control Council
Information provided by (Responsible Party):
John Sievenpiper, University of Toronto

Brief Summary:
Diabetes and heart associations continue to discourage high intakes of dietary fructose, a constituent part of the sucrose molecule that is found in fruits and vegetables as a natural sugar and in some processed foods and beverages as an added sweetener. The concern relates to its ability to increase certain blood fats and cholesterol, which increase the risk of cardiovascular disease. The evidence for an adverse effect of fructose on these risk factors, however, is inconclusive. To improve the evidence on which nutrition recommendations for fructose are based, the investigators therefore propose to study the effect of fructose on blood fats, cholesterol, sugars, blood pressure, and body weight, by undertaking a systematic synthesis of the data taken from all available clinical studies in humans. This technique has the strength of allowing all of the available data to be pooled together and differences to be explored in groups of different study participants (healthy humans of different sex, weight, and age and in those with diseases which predispose to disturbances in metabolism, such as diabetes) with dietary fructose in different forms, doses, and with differing durations of exposure. 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 or disease Intervention/treatment
Dyslipidemia Diabetes Prediabetes Dysglycemia Overweight Obesity Gout Hypertension Non-alcoholic Fatty Liver Disease Metabolic Syndrome Cardiovascular Disease Other: Dietary fructose

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Study Type : Observational
Estimated Enrollment : 1 participants
Official Title: Effect of Fructose on Metabolic Control in Humans: A Series of Systematic Reviews and Meta-analyses to Provide Evidence-based Guidance for Nutrition Guidelines Development
Study Start Date : May 2009
Actual Primary Completion Date : March 2014
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Fructose

Intervention Details:
  • Other: Dietary fructose
    Oral dietary fructose in free (unbound) form in isocaloric exchange for other non-fructose carbohydrate sources (isocaloric trials) or added to a control diet as a source of excess energy (hypercaloric trials).

Primary Outcome Measures :
  1. Lipid Analysis [ Time Frame: June 2012 ]


    1. Fasting lipids (triglycerides, HDL-cholesterol [C], LDL-C, apo-B, total-C:HDL-C ratio, apo-B:apo-A1 ratio, non-HDL-C)
    2. Postprandial lipids (peak, mean, and area under the curve [AUC] triglycerides)

  2. Body Weight Analysis [ Time Frame: November 2011 ]


    1. Body weight

  3. Glycemic Control Analysis [ Time Frame: June 2012 ]


    1. Glycated blood proteins (HbA1c, fructosamine, glycated albumin), glucose, and insulin in people with diabetes
    2. Glycated blood proteins (HbA1c, fructosamine, glycated albumin), glucose, and insulin in people without diabetes
    3. Insulin sensitivity (Euglycemic-hyperinsulinemic clamp, frequent sampling intravenous glucose tolerance test [FSIGT], Homeostasis model assessment of insulin resistance [HOMA-IR], oral glucose tolerance test insulin sensitivity index [OGTT-ISI])

  4. Blood Pressure (BP) Analysis [ Time Frame: January 2012 ]


    1. Systolic BP, diastolic BP, and mean arterial pressure (MAP)

  5. Uric Acid Analysis [ Time Frame: February 2012 ]


    1. uric acid

  6. "Catalytic" Fructose Across Cardiometabolic Endpoints Analysis [ Time Frame: January 2012 ]


    1. Lipids, glycemic control, body weight, blood pressure, and uric acid

  7. Non-Alcoholic Fatty Liver (NAFL) Analysis [ Time Frame: June 2012 ]


    1. Imaging and spectroscopy endpoints of liver fat (Liver ultrasound [US], computed tomography [CT], magnetic resonance imaging [MRI], or magnetic resonance spectroscopy [MRS]) and biomarkers of hepatocellular injury (transaminases [ALT, AST, GGT])

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Inclusion Criteria:

  • Trials in humans
  • Oral fructose intervention
  • Suitable control (i.e. another carbohydrate source in isocaloric exchange for fructose or a control diet which is compared with the same diet supplemented with excess energy from fructose)
  • >= 7-days diet duration
  • Viable endpoint data

Exclusion Criteria:

  • Non-human studies
  • IV or parenteral fructose
  • High fructose corn syrup or sucrose intervention (except where these are the comparators)
  • Lack of a suitable control
  • < 7-days diet duration.
  • No viable endpoint data

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363791

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Canada, Ontario
The Toronto 3D (Diet, Digestive tract and Disease) Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Micheal's Hospital
Toronto, Ontario, Canada, M5C 2N8
Sponsors and Collaborators
John Sievenpiper
Canadian Institutes of Health Research (CIHR)
Canada Research Chairs Endowment of the Federal Government of Canada
Calorie Control Council
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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
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
Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: John Sievenpiper, Adjunct Research Fellow, University of Toronto
ClinicalTrials.gov Identifier: NCT01363791    
Other Study ID Numbers: CIHR-KS-2009-205030
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Keywords provided by John Sievenpiper, University of Toronto:
Systematic review and meta-analysis
Evidence-based medicine (EBM)
Evidence-based nutrition (EBN)
Clinical practice guidelines
Clinical trials
Dietary sugars
High fructose corn syrup
Cardiometabolic risk factors
Glycemic control
Insulin resistance
Body weight
Uric acid
Blood pressure
Fatty liver
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Cardiovascular Diseases
Metabolic Syndrome
Body Weight
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Digestive System Diseases
Lipid Metabolism Disorders