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Meta-analysis of Fructose-Containing Sugar Sweetened Beverages (SSBs) and Weight Change

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ClinicalTrials.gov Identifier: NCT01608607
Recruitment Status : Unknown
Verified May 2015 by John Sievenpiper, University of Toronto.
Recruitment status was:  Active, not recruiting
First Posted : May 31, 2012
Last Update Posted : May 27, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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. Despite the uncertainties in the evidence,the recommendations of 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 effect of fructose-containing sugar sweetened beverages (SSBs)on 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
Overweight Obesity Diabetes Prediabetes Dysglycemia Metabolic Syndrome Other: Fructose-containing sugar sweetened beverages

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 1 participants
Time Perspective: Prospective
Official Title: Effect of Fructose-containing Sugar Sweetened Beverages (SSBs) on Body Weight: A Systematic Review and Meta-analysis of Controlled Feeding Trials to Provide Evidence-based Guidance for Nutrition Guidelines Development
Study Start Date : May 2012
Primary Completion Date : September 2014
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Fructose
U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Other: Fructose-containing sugar sweetened beverages
    Oral dietary fructose-containing sugar sweetened beverages in isocaloric exchange for other sources of carbohydrate (isocaloric trials) or hypercaloric exchange for beverages containing a non-nutritive sweetener or added to a control diet as a source of excess energy (hypercaloric trials)

Outcome Measures

Primary Outcome Measures :
  1. Body weight [ Time Frame: 1.5-years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Varied
Criteria

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
Contacts and Locations

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): NCT01608607


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. Micheal'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: NCT01608607     History of Changes
Other Study ID Numbers: CCC 2012 KRS
First Posted: May 31, 2012    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
Fructose
High fructose corn syrup
sucrose
Isocaloric
Hypercaloric
Glycemic control
Insulin resistance
Body weight
body mass index
waist circumference

Additional relevant MeSH terms:
Overweight
Metabolic Syndrome X
Prediabetic State
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases