NCT02629263

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. (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,394

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 14, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

October 29, 2019

Status Verified

October 1, 2019

Enrollment Period

3.7 years

First QC Date

November 27, 2015

Last Update Submit

October 28, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • HbA1c (%)

    3 weeks

Secondary Outcomes (4)

  • Fasting Blood Glucose (mmol/l)

    ≥ 3 weeks

  • Fasting Blood Insulin (pmol/l)

    ≥ 3 weeks

  • Fructosamine (mmol/l)

    ≥ 3 weeks

  • HOMA-IR (mU/mmol/l)

    ≥ 3 weeks

Interventions

Viscous FiberDIETARY_SUPPLEMENT

Meta- analysis of Randomized Controlled Trials

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study includes all population types.

You may qualify if:

  • 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.

You may not qualify if:

  • \--------

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition and Risk Factor Modification Centre

Toronto, Ontario, M5C 2T2, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Vladimir Vuksan, PhD

    St.Michael Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2015

First Posted

December 14, 2015

Study Start

September 1, 2015

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

October 29, 2019

Record last verified: 2019-10

Locations