Ignite Creation Date:
2024-05-06 @ 7:53 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02629263
Status:
COMPLETED
Last Update Posted:
2019-10-29
First Post:
2015-11-27
Brief Title:
The Effect of Viscous Fiber on Glycemic Control in Individuals With Diabetes
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
The Effect of Viscous Fibre on Glycemic Control in Individuals With Diabetes
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
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:
VFGC
Brief Summary:
Purpose of Study The Effect of Viscous Fiber on Glycemic Control VF GC in Individuals with Diabetes Mellitus
According to the World Health Organization about 347 million individuals are living with diabetes httpwwwwhointfeaturesfactfilesdiabetesfactsen accessed on Nov 23 2015 Over the last decades dietary fibers namely dietary viscous fibers have emerged as a nutrition component that may improve the postprandial glycemic response and hence aid in long term diabetes management It is believed that supplementation with viscous fibers can control blood glucose by increasing viscosity of the gastric digesta hence delaying gastric emptying and retarding entry of glucose into the bloodstream to result in a diminished postprandial rise in blood glucose Chutkan et al 2012
Currently the evidence of the relationship between viscous fibers and diabetes is mixed The systematic review method depends on combining data from many small studies in order to get a pooled estimate of the true effect The purpose of this study is to conduct a systematic review and meta-analysis of randomized controlled trials RCTs investigating the fasting glycemic and insulinemic effect of viscous fiber supplementation We hope the findings of this study will play a key role in developing the nutritional guidelines for individuals with diabetes mellitus
According to the World Health Organization about 347 million individuals are living with diabetes httpwwwwhointfeaturesfactfilesdiabetesfactsen accessed on Nov 23 2015 Over the last decades dietary fibers namely dietary viscous fibers have emerged as a nutrition component that may improve the postprandial glycemic response and hence aid in long term diabetes management It is believed that supplementation with viscous fibers can control blood glucose by increasing viscosity of the gastric digesta hence delaying gastric emptying and retarding entry of glucose into the bloodstream to result in a diminished postprandial rise in blood glucose Chutkan et al 2012
Currently the evidence of the relationship between viscous fibers and diabetes is mixed The systematic review method depends on combining data from many small studies in order to get a pooled estimate of the true effect The purpose of this study is to conduct a systematic review and meta-analysis of randomized controlled trials RCTs investigating the fasting glycemic and insulinemic effect of viscous fiber supplementation We hope the findings of this study will play a key role in developing the nutritional guidelines for individuals with diabetes mellitus
Detailed Description:
Background Diet high in total dietary fiber content has been recommended for individuals with diabetes mellitus However the effect of supplementing diet with viscous fiber such as guar gum beta glucan psyllium konjac or other viscous fibers on glycemic and insulinemic outcomes in individuals with diabetes mellitus is still controversial
Objective To improve the evidence-based guidelines recommendations for diabetes mellitus we will conduct a systematic review and meta-analysis on the effect of viscous fiber supplementation on glycemic control endpoints in individuals with diabetes mellitus
Design Cochrane handbook for systematic review of interventions will be used for planning and conducting this meta-analysis The reporting will follow the Preferred Reporting Items for Systematic Reviews and Meta-analyses PRISMA guidelines
Data sources MEDLINE EMBASE the Cochrane Central Register of Controlled Trials will be searched using appropriate pre-determined search terms
Study selection All the included trials must be randomized controlled with duration of 3 weeks investigating the effect of supplementing diet with viscous fiber on glycemic control outcomes in individuals with diabetes mellitus Acute studies non-randomized not appropriately controlled studies will be excluded Both isocaloric and non-isocaloric will be included
Data extraction Two independent reviewers will extract information about fiber type sample size subject characteristics dose follow-up composition of the background diets and statistical analyses MeanSEM values will be extracted for all outcomes Standard computation and imputation will be used to derive all missing variance data Risk of bias and study quality will be assessed using the Cochrane Risk of Bias Tool and the Grading of Recommendations Assessment Development and Evaluation GRADE respectively
Outcome This meta-analysis will assess a set of outcomes related to glycemic control in individuals with diabetes mellitus These outcomes are 1 glycated hemoglobin A1c HbA1c 2 fasting glucose FG 3 fasting insulin FI 4 fructosmine and 5 Homeostasis model assessment of insulin resistance HOMA-IR
Data synthesis Pooled analysis will be conducted using the Generic Inverse Variance method Rand-effects models will be used even in the absence of statistical significant between-study heterogeneity because they yield more conservative summary effect estimates in the presence of residual heterogeneity Heterogeneity will be assessed using Cochrans Q test and quantified by the I2 statistic Sensitivity and subgroup analyses will be used to explore sources of heterogeneity A prioir subgroup analyses include study design does fiber type follow-up duration baseline values study quality food matrix and composition of the background diet The significance of subgroup analyses will be assessed using meta-regression analyses Publication bias will be assessed using the inspection of funnel plots and application of Eggers and Beggs tests
Knowledge translation plan Results will be shared through traditional national and international scientific meetings and they will be submitted to high impact factor journals for publication
Significance We hope the results of this study will play a role in improving the guidelines recommendations for individuals with diabetes mellitus by raising the awareness towards viscous fiber consumption among health providers patients and industry Hopefully this study will aid in guiding future research in the dietary fiber field
Objective To improve the evidence-based guidelines recommendations for diabetes mellitus we will conduct a systematic review and meta-analysis on the effect of viscous fiber supplementation on glycemic control endpoints in individuals with diabetes mellitus
Design Cochrane handbook for systematic review of interventions will be used for planning and conducting this meta-analysis The reporting will follow the Preferred Reporting Items for Systematic Reviews and Meta-analyses PRISMA guidelines
Data sources MEDLINE EMBASE the Cochrane Central Register of Controlled Trials will be searched using appropriate pre-determined search terms
Study selection All the included trials must be randomized controlled with duration of 3 weeks investigating the effect of supplementing diet with viscous fiber on glycemic control outcomes in individuals with diabetes mellitus Acute studies non-randomized not appropriately controlled studies will be excluded Both isocaloric and non-isocaloric will be included
Data extraction Two independent reviewers will extract information about fiber type sample size subject characteristics dose follow-up composition of the background diets and statistical analyses MeanSEM values will be extracted for all outcomes Standard computation and imputation will be used to derive all missing variance data Risk of bias and study quality will be assessed using the Cochrane Risk of Bias Tool and the Grading of Recommendations Assessment Development and Evaluation GRADE respectively
Outcome This meta-analysis will assess a set of outcomes related to glycemic control in individuals with diabetes mellitus These outcomes are 1 glycated hemoglobin A1c HbA1c 2 fasting glucose FG 3 fasting insulin FI 4 fructosmine and 5 Homeostasis model assessment of insulin resistance HOMA-IR
Data synthesis Pooled analysis will be conducted using the Generic Inverse Variance method Rand-effects models will be used even in the absence of statistical significant between-study heterogeneity because they yield more conservative summary effect estimates in the presence of residual heterogeneity Heterogeneity will be assessed using Cochrans Q test and quantified by the I2 statistic Sensitivity and subgroup analyses will be used to explore sources of heterogeneity A prioir subgroup analyses include study design does fiber type follow-up duration baseline values study quality food matrix and composition of the background diet The significance of subgroup analyses will be assessed using meta-regression analyses Publication bias will be assessed using the inspection of funnel plots and application of Eggers and Beggs tests
Knowledge translation plan Results will be shared through traditional national and international scientific meetings and they will be submitted to high impact factor journals for publication
Significance We hope the results of this study will play a role in improving the guidelines recommendations for individuals with diabetes mellitus by raising the awareness towards viscous fiber consumption among health providers patients and industry Hopefully this study will aid in guiding future research in the dietary fiber field
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None