Meta-analyses of the Effect of Important Food Sources of Sugars on Cardiometabolic Risk Factors

NCT02716870 | Unknown

• 1 other identifier: CDA-Sugars 2015
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Fructose-containing sugars have been implicated in the epidemics of obesity, diabetes and related cardiometabolic disorders. 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 have been inconclusive. Whether sugars contribute to cardiometabolic complications independent of their calories remains 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 to distinguish the contribution of fructose-containing sugars from that of energy in the development of markers of cardiometabolic risk. 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.

Conditions

Dyslipidemia; Diabetes; Prediabetes; Dysglycemia; Gout; Hypertension; Non-alcoholic Fatty Liver Disease; Cardiovascular Disease

Keywords

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; Fatty liver; Fasting; Postprandial

Outcome Measures

Primary Outcomes (6)

• Glycemic Control

  glycated blood proteins, fasting blood glucose, fasting blood insulin

  Up to 20 years

• Established Therapeutic Blood Lipid Targets

  LDL-cholesterol, apol B, non-HDL-cholesterol, HDL-cholesterol, triglycerides

  Up to 20 years

• Blood Pressure

  Up to 20 years

• Uric Acid

  Blood uric acid concentrtaions

  Up to 20 years

• Non-Alcoholic Fatty Liver Disease (NAFLD)

  Intrahepatocellular lipid concentrations (IHCL), ALT

  Up to 20 years

• Inflammation

  c-reactive protein (CRP)

  Up to 20 years

Interventions

Fructose-containing Sugars OTHER

An intervention in which calories from fructose-containing sugars are substituted, added, or subtracted in the diet

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Trials in humans
• Oral fructose-containing sugars intervention
• Presence of an adequate comparator (substitution, addition, subtraction, or ad libitum control)
• Diet duration \>=7 days
• Viable outcome data

You may not qualify if:

• Non-human trials
• Observational studies
• IV or parenteral fructose-containing sugars
• Lack of suitable comparator (i.e. a comparator arm that contains substantial fructose-containing sugars)
• Diet duration \<7 days
• No viable outcome data

Sponsors & Collaborators

• University of Toronto: lead
• Canadian Diabetes Association: collaborator
• The Physicians' Services Incorporated Foundation: collaborator
• Banting & Best Diabetes Centre: collaborator

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 (10)

• 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: 22351714 BACKGROUND

• Ha V, Sievenpiper JL, de Souza RJ, Chiavaroli L, Wang DD, Cozma AI, Mirrahimi A, Yu ME, Carleton AJ, Dibuono M, Jenkins AL, Leiter LA, Wolever TM, Beyene J, Kendall CW, Jenkins DJ. Effect of fructose on blood pressure: a systematic review and meta-analysis of controlled feeding trials. Hypertension. 2012 Apr;59(4):787-95. doi: 10.1161/HYPERTENSIONAHA.111.182311. Epub 2012 Feb 13.

  PMID: 22331380 BACKGROUND

• Cozma AI, Sievenpiper JL, de Souza RJ, Chiavaroli L, Ha V, Wang DD, Mirrahimi A, Yu ME, Carleton AJ, Di Buono M, Jenkins AL, Leiter LA, Wolever TM, Beyene J, Kendall CW, Jenkins DJ. Effect of fructose on glycemic control in diabetes: a systematic review and meta-analysis of controlled feeding trials. Diabetes Care. 2012 Jul;35(7):1611-20. doi: 10.2337/dc12-0073.

  PMID: 22723585 BACKGROUND

• Chiavaroli L, de Souza RJ, Ha V, Cozma AI, Mirrahimi A, Wang DD, Yu M, Carleton AJ, Di Buono M, Jenkins AL, Leiter LA, Wolever TM, Beyene J, Kendall CW, Jenkins DJ, Sievenpiper JL. Effect of Fructose on Established Lipid Targets: A Systematic Review and Meta-Analysis of Controlled Feeding Trials. J Am Heart Assoc. 2015 Sep 10;4(9):e001700. doi: 10.1161/JAHA.114.001700.

  PMID: 26358358 BACKGROUND

• Wang DD, Sievenpiper JL, de Souza RJ, Chiavaroli L, Ha V, Cozma AI, Mirrahimi A, Yu ME, Carleton AJ, Di Buono M, Jenkins AL, Leiter LA, Wolever TM, Beyene J, Kendall CW, Jenkins DJ. The effects of fructose intake on serum uric acid vary among controlled dietary trials. J Nutr. 2012 May;142(5):916-23. doi: 10.3945/jn.111.151951. Epub 2012 Mar 28.

  PMID: 22457397 BACKGROUND

• Chiu S, Sievenpiper JL, de Souza RJ, Cozma AI, Mirrahimi A, Carleton AJ, Ha V, Di Buono M, Jenkins AL, Leiter LA, Wolever TM, Don-Wauchope AC, Beyene J, Kendall CW, Jenkins DJ. Effect of fructose on markers of non-alcoholic fatty liver disease (NAFLD): a systematic review and meta-analysis of controlled feeding trials. Eur J Clin Nutr. 2014 Apr;68(4):416-23. doi: 10.1038/ejcn.2014.8. Epub 2014 Feb 26.

  PMID: 24569542 BACKGROUND

• Liu Q, Chiavaroli L, Ayoub-Charette S, Ahmed A, Khan TA, Au-Yeung F, Lee D, Cheung A, Zurbau A, Choo VL, Mejia SB, de Souza RJ, Wolever TMS, Leiter LA, Kendall CWC, Jenkins DJA, Sievenpiper JL. Fructose-containing food sources and blood pressure: A systematic review and meta-analysis of controlled feeding trials. PLoS One. 2023 Aug 15;18(8):e0264802. doi: 10.1371/journal.pone.0264802. eCollection 2023.

  PMID: 37582096 DERIVED

• Qi X, Chiavaroli L, Lee D, Ayoub-Charette S, Khan TA, Au-Yeung F, Ahmed A, Cheung A, Liu Q, Blanco Mejia S, Choo VL, de Souza RJ, Wolever TMS, Leiter LA, Kendall CWC, Jenkins DJA, Sievenpiper JL. Effect of Important Food Sources of Fructose-Containing Sugars on Inflammatory Biomarkers: A Systematic Review and Meta-Analysis of Controlled Feeding Trials. Nutrients. 2022 Sep 26;14(19):3986. doi: 10.3390/nu14193986.

  PMID: 36235639 DERIVED

• Ayoub-Charette S, Chiavaroli L, Liu Q, Khan TA, Zurbau A, Au-Yeung F, Cheung A, Ahmed A, Lee D, Choo VL, Blanco Mejia S, de Souza RJ, Wolever TM, Leiter LA, Kendall CW, Jenkins DJ, Sievenpiper JL. Different Food Sources of Fructose-Containing Sugars and Fasting Blood Uric Acid Levels: A Systematic Review and Meta-Analysis of Controlled Feeding Trials. J Nutr. 2021 Aug 7;151(8):2409-2421. doi: 10.1093/jn/nxab144.

  PMID: 34087940 DERIVED

• Choo VL, Viguiliouk E, Blanco Mejia S, Cozma AI, Khan TA, Ha V, Wolever TMS, Leiter LA, Vuksan V, Kendall CWC, de Souza RJ, Jenkins DJA, Sievenpiper JL. Food sources of fructose-containing sugars and glycaemic control: systematic review and meta-analysis of controlled intervention studies. BMJ. 2018 Nov 21;363:k4644. doi: 10.1136/bmj.k4644.

  PMID: 30463844 DERIVED

MeSH Terms

Conditions

Dyslipidemias; Diabetes Mellitus; Prediabetic State; Gout; Hypertension; Non-alcoholic Fatty Liver Disease; Cardiovascular Diseases; Insulin Resistance; Body Weight; Fatty Liver; Fasting

Interventions

Fructose; Sucrose; High Fructose Corn Syrup; Honey

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Vascular Diseases; Liver Diseases; Digestive System Diseases; Hyperinsulinism; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses; Disaccharides; Oligosaccharides; Polysaccharides; Dietary Sugars; Dietary Carbohydrates; Nutritive Sweeteners; Sweetening Agents; Flavoring Agents; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• John L Sievenpiper, MD,PhD,FRCPC

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 23, 2016
• Study Start: June 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 25, 2020

Record last verified: 2020-06

Locations

CA (1)