Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04631913
Status:
UNKNOWN
Last Update Posted:
2020-11-17
First Post:
2020-11-16
Brief Title:
Meta-analysis of Oats for Diabetes Prevention and Management
Sponsor:
University of Toronto
Organization:
University of Toronto
Study Overview
Official Title:
Oats and Oat-fiber for Diabetes Prevention and Management A Systematic Review and Meta-analysis of Randomized Controlled Trials
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Oats are a commonly consumed source of viscous soluble fibre which has an established role in cardiovascular disease risk management including in cholesterol and glycemic control Oat beta-glucan is recognized for its cholesterol-lowering effects with approved health claims in Canada US and Europe However the efficacy of oat beta-glucan on glycemic control is not clear We propose to conduct a systematic review and meta-analysis to explore the efficacy of whole grain oats and oat beta-glucan on markers of glycemic control in people with without or at risk for diabetes
Detailed Description:
RATIONALE Although oat beta-glucan has approved health claims in Canada US and Europe 1-3 and is recognized by major cardiovascular guidelines 45 for its cholesterol-lowering there are no approved health claims for the maintenance or achievement of normal blood glucose 6 and its role in the prevention and management of diabetes are less clear We are not aware of any systematic reviews and meta-analyses of prospective cohort studies of the relation of the intake of whole oats oat products or oat beta-glucan with diabetes risk Although there are several systematic reviews and meta-analyses of randomized trials showing that oats and oat beta-glucan improve markers of glycemic control and insulin resistance 7-9 the census for theses analyses do not include new RCTs 10 Similar to an evidence synthesis that we conducted for all viscous fibers inclusive of oat beta-glucan 11 we propose to conduct the gold-standard in evidence synthesis a systematic review and meta-analysis of randomized trials using Grading of Recommendations Assessment Development and Evaluation GRADE system to quantify and assess the certainty of the evidence for the effect of oats and oat beta-glucan on established targets for glycemic control including HbA1c fasting glucose fasting insulin and measures of insulin sensitivity in participants stratified by their risk of diabetes
OBJECTIVES To quantify and assess the certainty of the evidence for the effect of oats and oat beta-glucan on established targets for glycemic control including HbA1c fasting plasma glucose FPG 2h-plasma glucose 2h-PG fasting plasma insulin and measures of insulin sensitivity and beta-cell function in participants who have diabetes are at risk of diabetes prediabetes metabolic syndrome or overweightobese or are otherwise healthy
DESIGN We will follow the Cochrane Handbook for Systematic Reviews of Interventions 12 and report according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses PRISMA 13 The protocol will be registered at wwwclinicaltrialsgov
DATA SOURCES MEDLINE EMBASE and The Cochrane Central Register of Controlled Trials will be searched for eligible trials We will also supplement our search with manual searches
STUDY SELECTION We will include randomized controlled trials of 2-weeks assessing the effect of whole grain oats or oat beta-glucan compared with a suitable non-oat control on established targets for glycemic control including HbA1c fasting plasma glucose 2h-plasma glucose 2h-PG fasting plasma insulin and measures of insulin resistance in participants with or without diabetes
DATA EXTRACTION Two or more investigators will independently extract relevant data Authors will be contacted for additional information and any missing data will be computedimputed using standard formulae 12
RISK OF BIAS Two or more investigators will independently assess risk of bias using the Cochrane Risk of Bias 20 Tool
OUTCOMES The outcomes will include established targets for glycemic control including HbA1c fasting plasma glucose FPG 2h-plasma glucose 2h-PG fasting plasma insulin and measures of hepatic insulin sensitivity HOMA-IR hyperinsulinemic euglycemic clamp whole body insulin sensitivity Matsuda OGTT-ISI frequently sampled intravenous glucose tolerance test FSIGTT hyperinsulinemic-euglycemic clamp and beta-cell function insulin secretion index ISSI-2
DATA SYNTHESIS Data will be pooled using the Generic Inverse Variance method stratified by risk of diabetes Random effects models will be used with paired analyses applied to crossover designs 14 Heterogeneity will be assessed Cochran Q statistic and quantified I2 statistic Sources of heterogeneity will be explored by sensitivity analyses If 10 trial comparisons are available a priori subgroup analyses will also be conducted to explore sources of heterogeneity dose comparator intervention form whole grain oat or oat beta-glucan follow-up baseline levels design body weight change saturated fat intake carbohydrate intake protein intake intervention food matrix oat beta-glucan molecular weight and risk of bias Meta-regression will assess the significance of subgroup analyses Linear and nonlinear dose-response analyses will be assessed by generalized least squares trend GLST estimation models and spline curve modelling MKSPLINE procedure respectively When 10 trial comparisons are available publication bias will be assessed by inspection of funnel plots and the Egger and Begg tests Adjustment for evidence of funnel plot asymmetry or small study effects will be conducted by the Duval and Tweedie trim-and-fill method
GRADE ASSESSMENT To assess the certainty of the evidence we will use the GRADE system an evidence-based grading system adopted by 100 organizations httpwwwgradeworkinggrouporg It grades the evidence as high moderate low or very low quality based on the study design and a series of downgrades risk of bias imprecision inconsistency indirectness publication bias and upgrades large magnitude of the effect dose-response gradient and attenuation by confounding We will follow the GRADE handbook httpsgdtgradeproorgapphandbookhandbookhtml and use the GRADEpro GRADEprofiler software Version 32
KNOWLEDGE TRANSLATION PLAN FOR IMPACT We will follow the Ottawa model of Research for knowledge translation 15 The results will be disseminated through interactive presentations at local national and international scientific meetings and publication in high impact journals Target audiences will include public health and clinical communities with an interest in nutrition and cardiovascular disease Feedback will be incorporated and used to improve public health messages and key areas for future research will be defined The PIs will network among opinion leaders to increase awareness and participate directly in the development of future guidelines
SIGNIFICANCE The proposed project will aid in knowledge translation related to the role of whole grain oats and oat fiber as add-on therapy in the primary and secondary prevention of cardiovascular disease strengthening the evidence-base for guidelines development in the US Canada Europe and beyond and improving health outcomes by educating healthcare providers and patients stimulating industry innovation and guiding future research design
REFERENCES
1 Food Directorate Health Products and Food Branch Health Canada Oat products and blood cholesterol lowering Bureau of Nutritional Sciences Ottawa 2010 Available at httpswwwcanadacaenhealth-canadaservicesfood-nutritionfood-labellinghealth-claimsassessmentsproducts-blood-cholesterol-lowering-summary-assessment-health-claim-about-products-blood-cholesterol-loweringhtml
2 US Food Drug Administration Health and Human Services Food Labeling Health Claims Soluble Dietary Fiber From Certain Foods and Coronary Heart Disease 21 CFR Part 101 Docket No 01Q-0313 Available at httpswwwgpogovfdsyspkgFR-2002-10-02pdf02-25067pdf
3 EFSA Panel on Dietetic Products Nutrition and Allergies NDA Scientific Opinion on the substantiation of a health claim related to oat beta-glucan and lowering blood cholesterol and reduced risk of coronary heart disease pursuant to Article 14 of Regulation EC No 19242006 EFSA J 8 12 2010 p 1885 102903jefsa20101885 Available at wwwefsaeuropaeuefsajournalhtm
4 Anderson TJ Grégoire J Pearson GJ Barry AR Couture P Dawes M Francis GA Genest J Jr Grover S Gupta M Hegele RA Lau DC Leiter LA Lonn E Mancini GB McPherson R Ngui D Poirier P Sievenpiper JL Stone JA Thanassoulis G Ward R 2016 Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the Prevention of Cardiovascular Disease in the Adult Can J Cardiol 2016 Nov32111263-1282
5 Catapano AL Graham I De Backer G Wiklund O Chapman MJ Drexel H Hoes AW Jennings CS Landmesser U Pedersen TR Reiner Ž Riccardi G Taskinen MR Tokgozoglu L Verschuren WMM Vlachopoulos C Wood DA Zamorano JL Cooney MT ESC Scientific Document Group 2016 ESCEAS Guidelines for the Management of Dyslipidaemias Eur Heart J 2016 Oct 1437392999-3058
6 European Food Safety Authority EFSA Scientific Opinion on the Substantiation of Health Claims Related to Beta-Glucans and Maintenance or Achievement of Normal Blood Glucose Concentrations ID 756 802 2935 Pursuant to Article 131 of Regulation EC No 192420062010 European Food Safety Authority EFSA Parma Italy 2010
7 Hou Q1 Li Y2 Li L3 Cheng G4 Sun X5 Li S6 Tian H7 The Metabolic Effects of Oats Intake in Patients with Type 2 Diabetes A Systematic Review and Meta-Analysis Nutrients 2015 Dec 1071210369-87 doi 103390nu7125536
8 Shen XL Zhao T Zhou Y Shi X Zou Y Zhao G Effect of Oat β-Glucan Intake on Glycaemic Control and Insulin Sensitivity of Diabetic Patients A Meta-Analysis of Randomized Controlled Trials Nutrients 2016 Jan 1381 pii E39 doi 103390nu8010039 Review
9 He LX Zhao J Huang YS Li Y The difference between oats and beta-glucan extract intake in the management of HbA1c fasting glucose and insulin sensitivity a meta-analysis of randomized controlled trials Food Funct 2016 Mar731413-28 doi 101039c5fo01364j
10 Li X Cai X Ma X Jing L Gu J Bao L Li J Xu M Zhang Z Li Y Short- and Long-Term Effects of Wholegrain Oat Intake on Weight Management and Glucolipid Metabolism in Overweight Type-2 Diabetics A Randomized Control Trial Nutrients 2016 Sep 789piiE549
11 Jovanovski E Khayyat R Zurbau A Komishon A Mazhar N Sievenpiper JL Blanco Mejia S Ho HVT Li D Jenkins AL Duvnjak L Vuksan V Should Viscous Fiber Supplements Be Considered in Diabetes Control Results From a Systematic Review and Meta-analysis of Randomized Controlled Trials Diabetes Care 2019 May425755-766
12 Higgins JPT Greens S editors Cochrane Handbook for Systematic Reviews of Interventions Version 510 updated March 2011 The Cochrane Collaboration 2011 Available from wwwcochrane-handbookorg
13 Moher D Liberati A Tetzlaff J Altman DG PRISMA Group Preferred reporting items for systematic reviews and meta-analyses the PRISMA statement BMJ 2009339b2535
14 Elbourne DR Altman DG Higgins JP Curtin F Worthington HV Vail A Meta-analyses involving cross-over trials Methodological issues Int J Epidemiol 200231140-149
15 Graham ID Logan J Innovations in knowledge transfer and continuity of care Can J Nurs Res 200436289-103
OBJECTIVES To quantify and assess the certainty of the evidence for the effect of oats and oat beta-glucan on established targets for glycemic control including HbA1c fasting plasma glucose FPG 2h-plasma glucose 2h-PG fasting plasma insulin and measures of insulin sensitivity and beta-cell function in participants who have diabetes are at risk of diabetes prediabetes metabolic syndrome or overweightobese or are otherwise healthy
DESIGN We will follow the Cochrane Handbook for Systematic Reviews of Interventions 12 and report according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses PRISMA 13 The protocol will be registered at wwwclinicaltrialsgov
DATA SOURCES MEDLINE EMBASE and The Cochrane Central Register of Controlled Trials will be searched for eligible trials We will also supplement our search with manual searches
STUDY SELECTION We will include randomized controlled trials of 2-weeks assessing the effect of whole grain oats or oat beta-glucan compared with a suitable non-oat control on established targets for glycemic control including HbA1c fasting plasma glucose 2h-plasma glucose 2h-PG fasting plasma insulin and measures of insulin resistance in participants with or without diabetes
DATA EXTRACTION Two or more investigators will independently extract relevant data Authors will be contacted for additional information and any missing data will be computedimputed using standard formulae 12
RISK OF BIAS Two or more investigators will independently assess risk of bias using the Cochrane Risk of Bias 20 Tool
OUTCOMES The outcomes will include established targets for glycemic control including HbA1c fasting plasma glucose FPG 2h-plasma glucose 2h-PG fasting plasma insulin and measures of hepatic insulin sensitivity HOMA-IR hyperinsulinemic euglycemic clamp whole body insulin sensitivity Matsuda OGTT-ISI frequently sampled intravenous glucose tolerance test FSIGTT hyperinsulinemic-euglycemic clamp and beta-cell function insulin secretion index ISSI-2
DATA SYNTHESIS Data will be pooled using the Generic Inverse Variance method stratified by risk of diabetes Random effects models will be used with paired analyses applied to crossover designs 14 Heterogeneity will be assessed Cochran Q statistic and quantified I2 statistic Sources of heterogeneity will be explored by sensitivity analyses If 10 trial comparisons are available a priori subgroup analyses will also be conducted to explore sources of heterogeneity dose comparator intervention form whole grain oat or oat beta-glucan follow-up baseline levels design body weight change saturated fat intake carbohydrate intake protein intake intervention food matrix oat beta-glucan molecular weight and risk of bias Meta-regression will assess the significance of subgroup analyses Linear and nonlinear dose-response analyses will be assessed by generalized least squares trend GLST estimation models and spline curve modelling MKSPLINE procedure respectively When 10 trial comparisons are available publication bias will be assessed by inspection of funnel plots and the Egger and Begg tests Adjustment for evidence of funnel plot asymmetry or small study effects will be conducted by the Duval and Tweedie trim-and-fill method
GRADE ASSESSMENT To assess the certainty of the evidence we will use the GRADE system an evidence-based grading system adopted by 100 organizations httpwwwgradeworkinggrouporg It grades the evidence as high moderate low or very low quality based on the study design and a series of downgrades risk of bias imprecision inconsistency indirectness publication bias and upgrades large magnitude of the effect dose-response gradient and attenuation by confounding We will follow the GRADE handbook httpsgdtgradeproorgapphandbookhandbookhtml and use the GRADEpro GRADEprofiler software Version 32
KNOWLEDGE TRANSLATION PLAN FOR IMPACT We will follow the Ottawa model of Research for knowledge translation 15 The results will be disseminated through interactive presentations at local national and international scientific meetings and publication in high impact journals Target audiences will include public health and clinical communities with an interest in nutrition and cardiovascular disease Feedback will be incorporated and used to improve public health messages and key areas for future research will be defined The PIs will network among opinion leaders to increase awareness and participate directly in the development of future guidelines
SIGNIFICANCE The proposed project will aid in knowledge translation related to the role of whole grain oats and oat fiber as add-on therapy in the primary and secondary prevention of cardiovascular disease strengthening the evidence-base for guidelines development in the US Canada Europe and beyond and improving health outcomes by educating healthcare providers and patients stimulating industry innovation and guiding future research design
REFERENCES
1 Food Directorate Health Products and Food Branch Health Canada Oat products and blood cholesterol lowering Bureau of Nutritional Sciences Ottawa 2010 Available at httpswwwcanadacaenhealth-canadaservicesfood-nutritionfood-labellinghealth-claimsassessmentsproducts-blood-cholesterol-lowering-summary-assessment-health-claim-about-products-blood-cholesterol-loweringhtml
2 US Food Drug Administration Health and Human Services Food Labeling Health Claims Soluble Dietary Fiber From Certain Foods and Coronary Heart Disease 21 CFR Part 101 Docket No 01Q-0313 Available at httpswwwgpogovfdsyspkgFR-2002-10-02pdf02-25067pdf
3 EFSA Panel on Dietetic Products Nutrition and Allergies NDA Scientific Opinion on the substantiation of a health claim related to oat beta-glucan and lowering blood cholesterol and reduced risk of coronary heart disease pursuant to Article 14 of Regulation EC No 19242006 EFSA J 8 12 2010 p 1885 102903jefsa20101885 Available at wwwefsaeuropaeuefsajournalhtm
4 Anderson TJ Grégoire J Pearson GJ Barry AR Couture P Dawes M Francis GA Genest J Jr Grover S Gupta M Hegele RA Lau DC Leiter LA Lonn E Mancini GB McPherson R Ngui D Poirier P Sievenpiper JL Stone JA Thanassoulis G Ward R 2016 Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the Prevention of Cardiovascular Disease in the Adult Can J Cardiol 2016 Nov32111263-1282
5 Catapano AL Graham I De Backer G Wiklund O Chapman MJ Drexel H Hoes AW Jennings CS Landmesser U Pedersen TR Reiner Ž Riccardi G Taskinen MR Tokgozoglu L Verschuren WMM Vlachopoulos C Wood DA Zamorano JL Cooney MT ESC Scientific Document Group 2016 ESCEAS Guidelines for the Management of Dyslipidaemias Eur Heart J 2016 Oct 1437392999-3058
6 European Food Safety Authority EFSA Scientific Opinion on the Substantiation of Health Claims Related to Beta-Glucans and Maintenance or Achievement of Normal Blood Glucose Concentrations ID 756 802 2935 Pursuant to Article 131 of Regulation EC No 192420062010 European Food Safety Authority EFSA Parma Italy 2010
7 Hou Q1 Li Y2 Li L3 Cheng G4 Sun X5 Li S6 Tian H7 The Metabolic Effects of Oats Intake in Patients with Type 2 Diabetes A Systematic Review and Meta-Analysis Nutrients 2015 Dec 1071210369-87 doi 103390nu7125536
8 Shen XL Zhao T Zhou Y Shi X Zou Y Zhao G Effect of Oat β-Glucan Intake on Glycaemic Control and Insulin Sensitivity of Diabetic Patients A Meta-Analysis of Randomized Controlled Trials Nutrients 2016 Jan 1381 pii E39 doi 103390nu8010039 Review
9 He LX Zhao J Huang YS Li Y The difference between oats and beta-glucan extract intake in the management of HbA1c fasting glucose and insulin sensitivity a meta-analysis of randomized controlled trials Food Funct 2016 Mar731413-28 doi 101039c5fo01364j
10 Li X Cai X Ma X Jing L Gu J Bao L Li J Xu M Zhang Z Li Y Short- and Long-Term Effects of Wholegrain Oat Intake on Weight Management and Glucolipid Metabolism in Overweight Type-2 Diabetics A Randomized Control Trial Nutrients 2016 Sep 789piiE549
11 Jovanovski E Khayyat R Zurbau A Komishon A Mazhar N Sievenpiper JL Blanco Mejia S Ho HVT Li D Jenkins AL Duvnjak L Vuksan V Should Viscous Fiber Supplements Be Considered in Diabetes Control Results From a Systematic Review and Meta-analysis of Randomized Controlled Trials Diabetes Care 2019 May425755-766
12 Higgins JPT Greens S editors Cochrane Handbook for Systematic Reviews of Interventions Version 510 updated March 2011 The Cochrane Collaboration 2011 Available from wwwcochrane-handbookorg
13 Moher D Liberati A Tetzlaff J Altman DG PRISMA Group Preferred reporting items for systematic reviews and meta-analyses the PRISMA statement BMJ 2009339b2535
14 Elbourne DR Altman DG Higgins JP Curtin F Worthington HV Vail A Meta-analyses involving cross-over trials Methodological issues Int J Epidemiol 200231140-149
15 Graham ID Logan J Innovations in knowledge transfer and continuity of care Can J Nurs Res 200436289-103
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None