Obesity Clinical Trial
Official title:
The Effect of 'Catalytic' Doses of Fructose and Its Epimers on Acute Postprandial Carbohydrate Metabolism and Longterm Glycemic Control: A Series of Systematic Reviews and Meta-analyses of Controlled Feeding Trials
Verified date | April 2017 |
Source | University of Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Despite advances in the prevention and treatment of type 2 diabetes, its prevalence continues to rise worldwide. There is a need for new modalities to improve metabolic control in individuals with type 2 diabetes and those who are overweight or obese and at risk for type 2 diabetes. Contrary to the concerns raised about the adverse role of fructose in metabolic health, various lines of evidence suggest that fructose and its epimers may improve the metabolic handling of glucose through inducing glycogen synthesis. Recent small trials in humans suggest that catalytic doses (=<10g/meal) of fructose and its epimers (allulose, tagatose, and sorbose) may reduce postprandial glycemic responses to carbohydrate loads (i.e., oral glucose tolerance test or a starch load) in people with and without type 2 diabetes. There is also limited evidence that these acute effects may manifest as longer term improvements in glycemic control. There is an urgent need to synthesize the evidence of the effects of fructose and its epimers on postprandial carbohydrate metabolism.
Status | Active, not recruiting |
Enrollment | 1 |
Est. completion date | January 2018 |
Est. primary completion date | January 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Controlled trials in humans - Acute single-bolus feeding of fructose, allulose, tagatose, or sorbose (>=2-hour profile) or chronic feeding of fructose, allulose, tagatose, or sorbose (>= 2-weeks diet duration) - Doses of fructose, allulose, tagatose, or sorbose of =<10g/meal for acute feeding trials or =<40g/day for chronic feeding trials - Adequate comparator (reference carbohydrate or control diet) - Outcome data reported Exclusion Criteria: - Non-human studies - observational studies - Lack of adequate comparator or control group - Doses of fructose, allulose, tagatose, or sorbose providing >10g/meal for acute feeding trials or >40g/day for chronic feeding trials - Follow-up <2-hours for acute feeding trials or < 2-weeks (diet duration) for chronic feeding trials - Lack of reported 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, Canadian Institutes of Health Research (CIHR), The Physicians' Services Incorporated Foundation |
Canada,
Donner TW, Wilber JF, Ostrowski D. D-tagatose, a novel hexose: acute effects on carbohydrate tolerance in subjects with and without type 2 diabetes. Diabetes Obes Metab. 1999 Sep;1(5):285-91. — View Citation
Hayashi N, Iida T, Yamada T, Okuma K, Takehara I, Yamamoto T, Yamada K, Tokuda M. Study on the postprandial blood glucose suppression effect of D-psicose in borderline diabetes and the safety of long-term ingestion by normal human subjects. Biosci Biotechnol Biochem. 2010;74(3):510-9. Epub 2010 Mar 7. — View Citation
Iida T, Kishimoto Y, Yoshikawa Y, Hayashi N, Okuma K, Tohi M, Yagi K, Matsuo T, Izumori K. Acute D-psicose administration decreases the glycemic responses to an oral maltodextrin tolerance test in normal adults. J Nutr Sci Vitaminol (Tokyo). 2008 Dec;54(6):511-4. — View Citation
Kwak JH, Kim MS, Lee JH, Yang YJ, Lee KH, Kim OY, Lee JH. Beneficial effect of tagatose consumption on postprandial hyperglycemia in Koreans: a double-blind crossover designed study. Food Funct. 2013 Aug;4(8):1223-8. doi: 10.1039/c3fo00006k. — View Citation
Wu T, Zhao BR, Bound MJ, Checklin HL, Bellon M, Little TJ, Young RL, Jones KL, Horowitz M, Rayner CK. Effects of different sweet preloads on incretin hormone secretion, gastric emptying, and postprandial glycemia in healthy humans. Am J Clin Nutr. 2012 Jan;95(1):78-83. doi: 10.3945/ajcn.111.021543. Epub 2011 Dec 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acute glycemic outcome - glycemic response | Incremental area under the curse (iAUC) blood glucose | Up to 20 years | |
Primary | Acute glycemic outcome - insulinemic response | Incremental area under the curse (iAUC) blood insulin | Up to 20 years | |
Primary | Acute glycemic outcome - whole body insulin sensitivity | Matsuda whole body insulin sensitivity index | Up to 20 years | |
Primary | Acute glycemic outcome - beta cell function | Early Insulin Secretion Index | Up to 20 years | |
Primary | Chronic glycemic outcome - HbA1c | HbA1c | Up to 20 years | |
Primary | Chronic glycemic outcome - fasting glucose | Fasting blood glucose | Up to 20 years | |
Primary | Chronic glycemic outcome - fasting insulin | Fasting blood insulin | Up to 20 years |
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