NCT02558920

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

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 Sep 2018

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

First Submitted

Initial submission to the registry

September 15, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
2.9 years until next milestone

Study Start

First participant enrolled

September 4, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

January 15, 2019

Status Verified

December 1, 2018

Enrollment Period

1.3 years

First QC Date

September 15, 2015

Last Update Submit

January 11, 2019

Conditions

Keywords

Systematic review and meta-analysisEvidence-based medicine (EBM)Evidence-based nutrition (EBN)Clinical practice guidelinesClinical trialsDietary sugarsFructoseSucroseHigh fructose corn syrupIsocaloricHypercaloricBody weightProspective cohort studies

Outcome Measures

Primary Outcomes (2)

  • Incident overweight or obesity (prospective cohort studies)

    Incident overweight or obesity

    Up to 20 years

  • Body weight (controlled trials)

    Body weight

    Up to 20 years

Secondary Outcomes (6)

  • Global measures of adiposity with established clinical relevance - body weight (prospective cohort studies)

    Up to 20 years

  • Global measures of adiposity with established clinical relevance - BMI (prospective cohort studies and controlled trials)

    Up to 20 years

  • Global measures of adiposity with established clinical relevance - body fat (prospective cohort studies and controlled trials)

    Up to 20 years

  • Abdominal measures of adiposity with established clinical relevance - waist circumference (prospective cohort studies and controlled trials)

    Up to 20 years

  • Abdominal measures of adiposity with established clinical relevance - waist-to-hip ratio (prospective cohort studies and controlled trials)

    Up to 20 years

  • +1 more secondary outcomes

Interventions

An intervention in which calories from food sources of fructose-containing sugars are substituted, added, subtracted, or replaced ad libitum in the diet

Also known as: fructose, sucrose, high-fructose corn syrup (HFCS)

Eligibility Criteria

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

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

You may qualify if:

  • 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
  • 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

You may not qualify if:

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

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 (4)

  • 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
  • Sievenpiper JL, de Souza RJ, Cozma AI, Chiavaroli L, Ha V, Mirrahimi A. Fructose vs. glucose and metabolism: do the metabolic differences matter? Curr Opin Lipidol. 2014 Feb;25(1):8-19. doi: 10.1097/MOL.0000000000000042.

    PMID: 24370846BACKGROUND
  • 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
  • Chiavaroli L, Cheung A, Ayoub-Charette S, Ahmed A, Lee D, Au-Yeung F, Qi X, Back S, McGlynn N, Ha V, Lai E, Khan TA, Blanco Mejia S, Zurbau A, Choo VL, de Souza RJ, Wolever TM, Leiter LA, Kendall CW, Jenkins DJ, Sievenpiper JL. Important food sources of fructose-containing sugars and adiposity: A systematic review and meta-analysis of controlled feeding trials. Am J Clin Nutr. 2023 Apr;117(4):741-765. doi: 10.1016/j.ajcnut.2023.01.023. Epub 2023 Feb 23.

MeSH Terms

Conditions

Body WeightObesityOverweightObesity, Abdominal

Interventions

FructoseSucroseHigh Fructose Corn Syrup

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesKetosesDisaccharidesOligosaccharidesPolysaccharidesDietary SugarsDietary CarbohydratesNutritive SweetenersSweetening AgentsFlavoring AgentsFood AdditivesFood IngredientsSpecialty Uses of ChemicalsChemical Actions and UsesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • John Sievenpiper, MD,PhD,FRCPC

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 15, 2015

First Posted

September 24, 2015

Study Start

September 4, 2018

Primary Completion

January 1, 2020

Study Completion

September 1, 2020

Last Updated

January 15, 2019

Record last verified: 2018-12

Locations