Obesity Clinical Trial
Official title:
Effect of Fructose on Metabolic Control in Humans: A Series of Systematic Reviews and Meta-analyses to Provide Evidence-based Guidance for Nutrition Guidelines Development
Verified date | May 2015 |
Source | University of Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Observational |
Diabetes and heart associations continue to discourage high intakes of dietary fructose, a constituent part of the sucrose molecule that is found in fruits and vegetables as a natural sugar and in some processed foods and beverages as an added sweetener. The concern relates to its ability to increase certain blood fats and cholesterol, which increase the risk of cardiovascular disease. The evidence for an adverse effect of fructose on these risk factors, however, is inconclusive. To improve the evidence on which nutrition recommendations for fructose are based, the investigators therefore propose to study the effect of fructose on blood fats, cholesterol, sugars, blood pressure, and 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.
Status | Active, not recruiting |
Enrollment | 1 |
Est. completion date | March 2016 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
N/A
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. Micheal's Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
John Sievenpiper | Calorie Control Council, Canada Research Chairs Endowment of the Federal Government of Canada, Canadian Institutes of Health Research (CIHR) |
Canada,
Chiavaroli L, Ha V, de Souza RJ, Kendall CW, Sievenpiper JL. Re. "Association of fructose consumption and components of metabolic syndrome in human studies: a systematic review and meta-analysis". Nutrition. 2015 Feb;31(2):419-20. doi: 10.1016/j.nut.2014. — View Citation
David Wang D, Sievenpiper JL, de Souza RJ, Cozma AI, Chiavaroli L, Ha V, Mirrahimi A, Carleton AJ, Di Buono M, Jenkins AL, Leiter LA, Wolever TM, Beyene J, Kendall CW, Jenkins DJ. Effect of fructose on postprandial triglycerides: a systematic review and m — 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-analysi — View Citation
Sievenpiper JL, Carleton AJ, Chatha S, Jiang HY, de Souza RJ, Beyene J, Kendall CW, Jenkins DJ. Heterogeneous effects of fructose on blood lipids in individuals with type 2 diabetes: systematic review and meta-analysis of experimental trials in humans. Diabetes Care. 2009 Oct;32(10):1930-7. doi: 10.2337/dc09-0619. Epub 2009 Jul 10. Review. — View Citation
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 harmi — View Citation
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. Review. — View Citation
Sievenpiper JL, de Souza RJ, Jenkins DJ. Sugar: fruit fructose is still healthy. Nature. 2012 Feb 22;482(7386):470. doi: 10.1038/482470e. Erratum in: Nature. 2012 Mar 22;483(7390):407. — View Citation
Sievenpiper JL, de Souza RJ, Kendall CW, Jenkins DJ. Is fructose a story of mice but not men? J Am Diet Assoc. 2011 Feb;111(2):219-20; author reply 220-2. doi: 10.1016/j.jada.2010.12.001. — 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-analy — View Citation
Sievenpiper JL; Toronto 3D (Diet, Digestive Tract, and Disease) Knowledge Synthesis and Clinical Trials Unit. Fructose: where does the truth lie? J Am Coll Nutr. 2012 Jun;31(3):149-51. 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 d — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lipid Analysis | Analyses: Fasting lipids (triglycerides, HDL-cholesterol [C], LDL-C, apo-B, total-C:HDL-C ratio, apo-B:apo-A1 ratio, non-HDL-C) Postprandial lipids (peak, mean, and area under the curve [AUC] triglycerides) |
June 2012 | No |
Primary | Body Weight Analysis | Analyses: 1. Body weight |
November 2011 | No |
Primary | Glycemic Control Analysis | Analyses: Glycated blood proteins (HbA1c, fructosamine, glycated albumin), glucose, and insulin in people with diabetes Glycated blood proteins (HbA1c, fructosamine, glycated albumin), glucose, and insulin in people without diabetes Insulin sensitivity (Euglycemic-hyperinsulinemic clamp, frequent sampling intravenous glucose tolerance test [FSIGT], Homeostasis model assessment of insulin resistance [HOMA-IR], oral glucose tolerance test insulin sensitivity index [OGTT-ISI]) |
June 2012 | No |
Primary | Blood Pressure (BP) Analysis | Analyses: 1. Systolic BP, diastolic BP, and mean arterial pressure (MAP) |
January 2012 | No |
Primary | Uric Acid Analysis | Analyses: 1. uric acid |
February 2012 | No |
Primary | "Catalytic" Fructose Across Cardiometabolic Endpoints Analysis | Analyses: 1. Lipids, glycemic control, body weight, blood pressure, and uric acid |
January 2012 | No |
Primary | Non-Alcoholic Fatty Liver (NAFL) Analysis | Analyses: 1. Imaging and spectroscopy endpoints of liver fat (Liver ultrasound [US], computed tomography [CT], magnetic resonance imaging [MRI], or magnetic resonance spectroscopy [MRS]) and biomarkers of hepatocellular injury (transaminases [ALT, AST, GGT]) |
June 2012 | No |
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