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Home , Isomaltulose, Tagatose

RARE AND GLYCEMIC CONTROL: SYSTEMATIC REVIEWAND META-ANALYSIS OF CONTROLLED INTERVENTION TRIALS

Amna Ahmed1,2, Tauseef Ahmad Khan1,2, Laura Chiavaroli1,2, John L Sievenpiper1-4

1Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, 2 Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael’s Hospital 3Division of Endocrinology and Metabolism, 4Li Ka Shing Knowledge Institute, St. Michael’s Hospital, Toronto, ON, Canada

ABSTRACT RESULTS Introduction: Common sugars including and high corn syrup have been implicated in the epidemics of and type 2 . Rare sugars are Search results and their derivatives that are present in limited quantities in nature with divergent metabolic effects in humans. To assess the effect of different rare sugars on glycemic control, we conducted a systematic review and meta-analysis of 3 Allulose trial comparisons randomized controlled trials in individuals with and without diabetes. 13 included in analysis = 14 trial 3 trial comparisons 882 Reports identified 869 Excluded after review Methods: MEDLINE, Embase, and Cochrane Library were searched up to 1 October comparisons N=893 participants 3 trial comparisons 2020, supplemented with manual searches. We included randomized controlled trials of 5 trial comparisons ≥1 weeks’ duration and assessing the effect of different rare sugars on glycemic 0 trial comparisons control. Two independent reviewers extracted relevant data and assessed risk of bias (Cochrane Risk of Bias tool). The primary outcome was HbA1c. Secondary outcomes included fasting , and fasting . Data were pooled using the inverse Trial characteristics variance method with random effects models and expressed as mean differences (MDs) with 95% confidence intervals (CIs). The certainty of the evidence was assessed using GRADE. Trial characteristics Allulose Tagatose Trehalose Isomaltulose Results: We included 13 randomized controlled trials (14 trial comparisons, n=893) Trials (N) 3 3 3 5 that assessed four different rare sugars (tagatose, allulose, isomaltulose, and trehalose) compared with common sugars (sucrose, glucose, , or fructose) or Participants (median N (range)) 60 (17-61) 12 (8-356) 34 (32-50) 82 (81-83) low-calorie sweeteners () in people with and without diabetes . Tagatose reduced HbA1c (MD, -0.20% [95% CI, -0.34 to -0.06], p=0.004) and fasting blood Healthy mixed weight=1, Healthy mixed weight=2, Healthy mixed weight=1, Underlying disease status (N trials) Healthy mixed weight=2, T2D=1 glucose (MD, -0.30 mmol/L [95% CI, -0.57 to -0.04], p=0.02). Both allulose (MD, -0.18 OW/OB=2 OW/OB=1 OW/OB=1, T2D=2, HLD=1 mmol/L [95% CI, -0.35 to -0.00], p=0.05) and isomaltulose (MD, -0.19 mmol/L [95% CI, -0.33 to -0.05], p=0.007) reduced fasting blood glucose but not HbA1c or fasting insulin. Age (median years (range)) 27.2 (26.2-34) 38.9 (21-51.7) 47.9 (43.7-63) NR Trehalose had no effect on any outcome. The certainty of the evidence was moderate to low for most rare -outcome relationships. Baseline HbA1c (median %) (range)) 5.44 (4.65-5.45) 7.51 5.38 (5.35-5.4) 5.98 (5.05-7.29) Baseline fasting glucose (median mmol/L Conclusions: Rare sugars, specifically tagatose, allulose, and isomaltulose, improve 5.21 (5.11-5.26) 6.21 (4.94-7.48) 4.97 (4.72-5.15) 5.26 (4.3-7.97) glycemic control. The evidence gives a good indication of the small benefits in HbA1c (range)) and fasting blood glucose that would be expected when these rare sugars are Baseline fasting insulin (median pmol/L substituted mainly for common sugars in people with and without diabetes. More high- 50.93 (50.24-50.93) 66.71 (59.8-73.62) 42.19 (35.42-48.96) 65.14 (35.49-77.28) quality randomized controlled trials are needed to improve our estimates. (range))

Primary Funding Source: ILSI Rare sugars dose (median g (range)) 14 (8-15) 45 (30-45) 11 (3.3-100) 50 (16.5-50) INTRODUCTION Follow-up duration (median weeks (range)) 12 (12-12) 4 (2-40) 12 (12-12) 12 (4-12) Rare sugars, with subtle differences in their Rare sugar form (N trials) Liquid=3 Liquid=1, Solid=1, Mixed=1 Liquid=1, Mixed=2 Liquid=1, Mixed=4 chemical composition compared to traditional Comparator (N trials) Glucose=1, Sucralose=2 Sucrose=2, Sucralose=1 Sucrose=1, Maltose=1 Sucrose=4, Mixed=1 sugars, have demonstrated unique effects on glycemic control but the extent of this effect is OW/OB = or obese, T2D = , HLD = hyperlipidemic unknown.1 Results We aim to conduct a systematic review and meta- analysis of controlled feeding trials in people with and without diabetes on the effect of different rare sugars on glycemic control. METHODS Protocol Conduct: Cochrane Handbook for Systematic Reviews of Interventions2 Reporting: PRISMA guidelines3

Databases

Searched (through to December 2nd, 2020). Manual searches of the reference lists of included studies complemented the systematic search. PICOTS framework Participants Adult individuals with and without diabetes Interventions Rare sugars CI=confidence interval; GRADE=Grading of Recommendations, Assessment, Development and Evaluation; MD=mean difference; pMD=p-value for the overall effect; pQ= Comparators Common sugars (sucrose, Cochrane’s Q statistic glucose, maltose, or fructose), White boxes: no upgrades or downgrades were made; Black boxes: single downgrade or upgrade non-nutritive sweetener, no sugar Outcomes Glycosylated hemoglobin, fasting glucose, fasting insulin - Tagatose reduced Hba1c and fasting blood glucose but not fasting insulin. Time ≥7 days - Allulose and isomaltulose reduced fasting blood glucose but not HbA1c or fasting insulin. Study design Randomized and non- - Trehalose had no effect on any of the outcomes. Randomized controlled trials done - The certainty of the evidence was moderate to low for most rare sugar-outcome relationships due to indirectness in humans (limited number of trials identified and/or lack of generalizability), inconsistency (substantial heterogeneity, and imprecision (all CIs crossed the MID for harm and/or benefit). Primary analysis Risk of bias Generic inverse variance using random Cochrane CONCLUSIONS REFERENCES effects models (MD, 95%CI) 1Van Laar et al. Critical Reviews in Food and Nutrition. 2020 Risk-of-Bias 2Higgins et al. Cochrane Handbook for Systematic Reviews of - Rare sugars, specifically allulose, tagatose, and isomaltulose improve glycemic Interventions version 6.0 2019. Tool 3 Heterogeneity Moher et al. Journal of Clinical Epidemiology. 2009 Certainty of control compared to traditional sugars. Cochrane’s Q (p<0.1); Quantified by I2 - None of the rare sugars had effects on fasting insulin. ACKNOWLEDGEMENTS (≥50%). the evidence - The evidence gives a good indication of the small benefits in HbA1c and fasting Publication bias Grading of blood glucose that would be expected when these rare sugars are substituted Recommendations Funnel Plots asymmetry mainly for common sugars in people with and without diabetes. Assessment, Egger’s and Begg’s test (P<0.100 - More high-quality trials of different rare sugars are needed to improve our ) Development and Evaluation estimates. Publishing Date: January 2021. © 2021. All rights reserved. Copyright rests with the author. (GRADE) No part of this abstract/poster may be reproduced without written permission from the author.