Diabetes Mellitus, Type 2 Clinical Trial
— VF&GCOfficial title:
The Effect of Viscous Fibre on Glycemic Control in Individuals With Diabetes
Verified date | October 2019 |
Source | St. Michael's Hospital, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1394 |
Est. completion date | May 2019 |
Est. primary completion date | May 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
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: -------- |
Country | Name | City | State |
---|---|---|---|
Canada | Clinical Nutrition and Risk Factor Modification Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
St. Michael's Hospital, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HbA1c (%) | 3 weeks | ||
Secondary | Fasting Blood Glucose (mmol/l) | = 3 weeks | ||
Secondary | Fasting Blood Insulin (pmol/l) | = 3 weeks | ||
Secondary | Fructosamine (mmol/l) | = 3 weeks | ||
Secondary | HOMA-IR (mU/mmol/l) | = 3 weeks |
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