Fibre Grain Herb Trial in Type 2 Diabetes

Study Overview
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Brief Summary
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Despite the availability of multiple medications for the treatment of Type 2 diabetes, patients often continue to have difficulty attaining blood glucose targets and managing cardiovascular disease risk factors. Recent trends in non-pharmacological therapy have created a growing public interest in dietary supplements. Research by this group and others support the benefits of whole grains, viscous dietary fibre and ginseng in the management of diabetes. The current study investigates whether the co-administration of a viscous dietary fibre blend, Salba (a grain rich in omega-3 fatty acids), and 2 varieties of ginseng roots will further improve blood sugar control and cardiovascular disease risk outcomes in individuals with Type 2 diabetes already receiving conventional treatments. Patients with Type 2 diabetes receiving the recommended intervention in accordance with the Canadian Diabetes Association guidelines will be enrolled in a 6-month clinical study. Half of the participants will be randomly assigned to a 4-component intervention that comprises the co-administration of these four dietary/herbal supplements in addition to their usual treatment regimen; the other half will continue their usual treatment regimen in addition to taking high-oat fiber and wheat bran supplements. The investigators hypothesize that an intensified, multi-targeted intervention with the addition of these dietary and herb components will further improve long-term blood glucose control and cardiovascular disease risk factors beyond conventional therapy. If this combination of viscous fiber, Salba and ginseng is shown to be beneficial, these remedies could complement current conventional therapy for Type 2 diabetes with the goal to further improve health outcomes.

Official Title
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Co-administration of Three Complimentary Therapies (Viscous Dietary Fiber, Whole Grain and Ginseng) for Comprehensive Risk Reduction in Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Dietary, Herbal
* Dietary Supplement: Positive Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes medically diagnosed for at least 6-months prior to randomization HbA1c (glycated hemoglobin) between 6.3% and 8.5% at screening BMI < 35 kg/m2 Exclusion Criteria: Insulin therapy Blood pressure ≥ 160/100 mmHg Serum triglyceride >4.5mmol/L History of major cardiovascular events (stroke or myocardial infarction) Gastrointestinal, liver or kidney disease Consumption of alcohol >2 drinks/day Current tobacco smokers Taking the following medications: herbs or supplements that may affect primary or secondary outcomes, monoamine oxidase inhibitors (MAOIs) antidepressants and/or anticoagulant therapy Women with hormone sensitive tumors/conditions

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary, Herbal<br> | Dietary Supplement: Dietary, Herbal<br>* Viscous fibre blend and Salba and American and Korean Red Ginseng capsules<br>|
| Placebo Comparator: Positive Control<br> | Dietary Supplement: Positive Control<br>* Oat bran blend and wheat bran capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | Assessed via laboratory analysis | Baseline to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LDL-C | Assessed via laboratory analysis | Baseline to 24 weeks | 
| Change in 24h ambulatory systolic blood pressure | Assessed via analysis | Baseline to 24 weeks |