The Effect of Viscous Fiber on Glycemic Control in Individuals With Diabetes (VF&GC)

October 28, 2019 updated by: Unity Health Toronto

The Effect of Viscous Fibre on Glycemic Control in Individuals With Diabetes

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. (http://www.who.int/features/factfiles/diabetes/facts/en/, 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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. 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), (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 Cochran's 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 Egger's and Begg's 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 Type

Observational

Enrollment (Actual)

1394

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5C 2T2
        • Clinical Nutrition and Risk Factor Modification Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study includes all population types.

Description

Inclusion Criteria:

  • Randomized Controlled Trials
  • Parallel or Crossover Design
  • Duration: ≥ 3 weeks
  • Food/ Supplements.
  • Soluble Fibers include: B-Glucan, Guar Gum, Konjac, Pectin, Psyllium.
  • Diabetes Biomarkers include: Fasting Blood Glucose, Fasting Insulin, Fructosamine, and HbA1c.

Exclusion Criteria:

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c (%)
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting Blood Glucose (mmol/l)
Time Frame: ≥ 3 weeks
≥ 3 weeks
Fasting Blood Insulin (pmol/l)
Time Frame: ≥ 3 weeks
≥ 3 weeks
Fructosamine (mmol/l)
Time Frame: ≥ 3 weeks
≥ 3 weeks
HOMA-IR (mU/mmol/l)
Time Frame: ≥ 3 weeks
≥ 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Investigators

  • Principal Investigator: Vladimir Vuksan, PhD, St.Michael Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

November 27, 2015

First Submitted That Met QC Criteria

December 9, 2015

First Posted (Estimate)

December 14, 2015

Study Record Updates

Last Update Posted (Actual)

October 29, 2019

Last Update Submitted That Met QC Criteria

October 28, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Viscous Fiber and GC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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