Meta-analyses of the Effect of 'Catalytic' Doses of Fructose and Its Epimers on Carbohydrate Metabolism

NCT02776722 | Unknown

• 1 other identifier: UT-Fructose epimers
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight; Obesity; Dysglycemia; Prediabetes; Metabolic Syndrome; Type 2 Diabetes

Keywords

Systematic Review and Meta-analysis; randomized controlled trial; Evidence-Based Medicine; carbohydrate metabolism; postprandial; glycemic response; glycemic control; insulin sensitivity; beta-cell function; sugars; fructose; allulose; tagatose; sorbose

Outcome Measures

Primary Outcomes (7)

• Acute glycemic outcome - glycemic response

  Incremental area under the curse (iAUC) blood glucose

  Up to 20 years

• Acute glycemic outcome - insulinemic response

  Incremental area under the curse (iAUC) blood insulin

  Up to 20 years

• Acute glycemic outcome - whole body insulin sensitivity

  Matsuda whole body insulin sensitivity index

  Up to 20 years

• Acute glycemic outcome - beta cell function

  Early Insulin Secretion Index

  Up to 20 years

• Chronic glycemic outcome - HbA1c

  HbA1c

  Up to 20 years

• Chronic glycemic outcome - fasting glucose

  Fasting blood glucose

  Up to 20 years

• Chronic glycemic outcome - fasting insulin

  Fasting blood insulin

  Up to 20 years

Interventions

fructose, allulose, tagatose, or sorbose OTHER

Single-bolus feeding of fructose, allulose, tagatose, or sorbose given together with a reference carbohydrate(s) compared with the same reference carbohydrate(s) alone for acute feeding trials or chronic feeding of fructose, allulose, tagatose, or sorbose provided in substitution for other reference carbohydrates or added to a control diet compared with the reference carbohydrate(s) alone or the control diet alone for chronic feeding trials.

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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead
• Canadian Diabetes Association: collaborator
• The Physicians' Services Incorporated Foundation: collaborator
• Banting & Best Diabetes Centre: collaborator
• Canadian Institutes of Health Research (CIHR): 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 (5)

• 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.

  PMID: 22158727 BACKGROUND

• 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. doi: 10.1271/bbb.90707. Epub 2010 Mar 7.

  PMID: 20208358 BACKGROUND

• 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. doi: 10.3177/jnsv.54.511.

  PMID: 19155592 BACKGROUND

• 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. doi: 10.1046/j.1463-1326.1999.00039.x.

  PMID: 11225640 BACKGROUND

• 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.

  PMID: 23760573 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity; Prediabetic State; Metabolic Syndrome; Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Fructose; psicose; tagatose; Sorbose

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 14, 2016
• First Posted: May 18, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: April 17, 2017

Record last verified: 2017-04

Locations

CA (1)