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Trial record 33 of 80 for:    ASNS

Meta-analyses of Food Sources of Fructose-Containing Sugars and Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02558920
Recruitment Status : Active, not recruiting
First Posted : September 24, 2015
Last Update Posted : January 15, 2019
Sponsor:
Collaborators:
American Society for Nutrition
The Physicians' Services Incorporated Foundation
Canadian Diabetes Association
Information provided by (Responsible Party):
John Sievenpiper, University of Toronto

Brief Summary:
Sugars have been implicated in the epidemics of overweight and obesity. This view is supported by lower quality evidence from ecological observations, animal models, and select human trials. Higher level evidence from controlled trials and prospective cohort studies has been inconclusive. Whether sugars contribute to weight gain or increases in adiposity independent of their calories and whether important food sources of sugars other than SSBs are associated with a higher risk of overweight and obesity or weight gain remain unclear. To address the uncertainties, the investigators propose to conduct a series of systematic reviews and meta-analyses of the totality of the evidence from controlled trials and prospective cohort studies to distinguish the contribution of fructose-containing sugars and important food sources of sugars (SSBs, fruit, 100% fruit juice, cakes/sweets, yogurt, cereals, etc) from that of energy in the development of overweight and obesity. The findings generated by this proposed knowledge synthesis will help improve the health of consumers through informing evidence-based guidelines and improving health outcomes by educating healthcare providers and patients, stimulating industry innovation, and guiding future research design

Condition or disease Intervention/treatment
Body Weight Obesity Overweight Adiposity Obesity, Abdominal Other: Fructose-containing Sugars

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Important Food Sources of Fructose-Containing Sugars and Markers of Adiposity and Risk of Obesity: A Series of Systematic Reviews and Meta-Analyses of Controlled Trials and Prospective Cohort Studies
Actual Study Start Date : September 4, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Fructose


Intervention Details:
  • Other: Fructose-containing Sugars
    An intervention in which calories from food sources of fructose-containing sugars are substituted, added, subtracted, or replaced ad libitum in the diet
    Other Name: fructose, sucrose, high-fructose corn syrup (HFCS)


Primary Outcome Measures :
  1. Incident overweight or obesity (prospective cohort studies) [ Time Frame: Up to 20 years ]
    Incident overweight or obesity

  2. Body weight (controlled trials) [ Time Frame: Up to 20 years ]
    Body weight


Secondary Outcome Measures :
  1. Global measures of adiposity with established clinical relevance - body weight (prospective cohort studies) [ Time Frame: Up to 20 years ]
    Body weight

  2. Global measures of adiposity with established clinical relevance - BMI (prospective cohort studies and controlled trials) [ Time Frame: Up to 20 years ]
    Body mass index (BMI)

  3. Global measures of adiposity with established clinical relevance - body fat (prospective cohort studies and controlled trials) [ Time Frame: Up to 20 years ]
    Body fat

  4. Abdominal measures of adiposity with established clinical relevance - waist circumference (prospective cohort studies and controlled trials) [ Time Frame: Up to 20 years ]
    Waist circumference

  5. Abdominal measures of adiposity with established clinical relevance - waist-to-hip ratio (prospective cohort studies and controlled trials) [ Time Frame: Up to 20 years ]
    Waist-to-hip ratio

  6. Abdominal measures of adiposity with established clinical relevance - Visceral Adipose tissue (prospective cohort studies and controlled trials) [ Time Frame: Up to 2 years ]
    Visceral Adipose tissue (VAT)



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

Inclusion Criteria for controlled trials:

  • Randomized and non-randomized controlled intervention studies in humans
  • Oral fructose-containing sugars intervention
  • Presence of a reduced fructose-containing sugars comparator in one of 4 energy controlled designs (substitution, addition, subtraction, or ad libitum)
  • Diet duration >=2 weeks
  • Viable outcome data

Inclusion Criteria for prospective cohort studies:

  • Prospective cohort studies
  • Duration >= 1 year
  • Assessment of the exposure of food sources of fructose-containing sugars
  • Ascertainment of viable outcome data by level of exposure

Exclusion Criteria for controlled trials:

  • Observational studies or intervention studies with no control group
  • IV or parenteral fructose-containing sugars intervention
  • Lack of an adequate comparator (i.e. lack of a difference (<5 g) in fructose-containing sugars between the intervention and control diets)

Exclusion Criteria for prospective cohort studies:

  • Ecological, cross-sectional, or retrospective observational studies
  • Intervention studies

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): NCT02558920


Locations
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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. Michael's Hospital
Toronto, Ontario, Canada, M5C 2T2
Sponsors and Collaborators
John Sievenpiper
American Society for Nutrition
The Physicians' Services Incorporated Foundation
Canadian Diabetes Association
Investigators
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Principal Investigator: John Sievenpiper, MD,PhD,FRCPC University of Toronto

Publications:
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Responsible Party: John Sievenpiper, Associate Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT02558920     History of Changes
Other Study ID Numbers: ASN-Sugars 2015
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: December 2018
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
Sucrose
High fructose corn syrup
Isocaloric
Hypercaloric
Body weight
Prospective cohort studies
Additional relevant MeSH terms:
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Obesity
Obesity, Abdominal
Overweight
Body Weight
Overnutrition
Nutrition Disorders
Signs and Symptoms