Diabetes Mellitus Clinical Trial
Official title:
The Effect of Non-Viscous Fibre Supplementation on Glycemic Control in Individuals With Diabetes Mellitus: A Systematic Review & Meta-analysis of RCTs
Purpose of Study (The Effect of Non-Viscous Fibre Supplementation on Glycemic Control (NVFS &
GC) in Individuals with Diabetes Mellitus.
Regardless of the remarkable advancement in pharmacotherapy, diabetes mellitus remains a
major concern with more than 300 millions living with its complications including CVD.
Nutrition is a cornerstone in diabetes management, and increasing total dietary fibre have
been shown to decrease HbA1c, fasting glucose, fasting insulin, fructosamine, and HOMA-IR.
However, the main underlying mechanism is still not fully understood, and the specific type
and proportion of fibre supplementation to be recommended for such individuals is still
controversial.
Currently, the available findings/ results from small RCTs are inconsistent. The systematic
review method depends on combining data from many small studies in order a pooled estimate of
the pooled effect. The purpose of this study is to conduct a systematic review and
meta-analysis of randomized controlled trials (RCTs) assessing the effect of non-viscous
fibre supplementation on fasting glucose and insulin in individuals with diabetes mellitus.
We hope the findings of this study will play a role in developing the nutritional guidelines
for individuals with diabetes mellitus.
Background: High fibre diets have been recommended for individuals with diabetes mellitus.
However, the findings on the effect of non-viscous fibre supplementation such as inulin,
wheat bran and resistant starch on glycemic control in individuals with diabetes are
inconsistent.
Objective: In order to improve the evidence-based guidelines for diabetes mellitus, we will
conduct a systematic review and meta-analysis to assess evidence from randomized controlled
trials (RCTs) on the effect of non-viscous fibre supplementation on glycemic control in
individuals with diabetes.
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-analysis (PRISMA) guidelines.
Data sources: MEDLINE, EMBASE, the Cochrane Central Register for 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 non-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. Mean±SEM 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)
or (2) fructosamine, (3) fasting glucose (FG), (4) fasting insulin (FI), 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 Cochran's Q test and
quantified by the I2 statistic. Sensitivity and subgroup analyses will be used to explore
sources of heterogeneity. A priori 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 Egger's and Begg's tests.
Knowledge translation plan: Results will be shared through traditional, national, and
international scientific meetings and they may 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.
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