Hypertension Clinical Trial
Official title:
Effect of Important Food Sources of Fructose-containing Sugars on Cardiometabolic Risk Factors: A Series of Systematic Reviews and Meta-analyses of Controlled Trials to Inform Dietary Guidelines, Public Health Policy, and Future Trial Design
Verified date | June 2020 |
Source | University of Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 1 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | 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 |
Lead Sponsor | Collaborator |
---|---|
University of Toronto | Banting & Best Diabetes Centre, Canadian Diabetes Association, The Physicians' Services Incorporated Foundation |
Canada,
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. Review. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glycemic Control | glycated blood proteins, fasting blood glucose, fasting blood insulin | Up to 20 years | |
Primary | Established Therapeutic Blood Lipid Targets | LDL-cholesterol, apol B, non-HDL-cholesterol, HDL-cholesterol, triglycerides | Up to 20 years | |
Primary | Blood Pressure | Up to 20 years | ||
Primary | Uric Acid | Blood uric acid concentrtaions | Up to 20 years | |
Primary | Non-Alcoholic Fatty Liver Disease (NAFLD) | Intrahepatocellular lipid concentrations (IHCL), ALT | Up to 20 years | |
Primary | Inflammation | c-reactive protein (CRP) | Up to 20 years |
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