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| Name | Class |
|---|---|
| Canadian Diabetes Association | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary, Herbal | Experimental |
| |
| Positive Control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary, Herbal | Dietary Supplement | Viscous fibre blend and Salba and American and Korean Red Ginseng capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Assessed via laboratory analysis | Baseline to 24 weeks |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting glucose | Assessed via laboratory analysis | Baseline to 24 weeks |
| Change in fasting insulin | Assessed via laboratory analysis |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hopsital | Toronto | Ontario | M5B 1M4 | Canada | ||
| Clinical Centre Vuk Vrhovac, Merkur Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33486572 | Derived | Zurbau A, Smircic Duvnjak L, Magas S, Jovanovski E, Miocic J, Jenkins AL, Jenkins DJA, Josse RG, Leiter LA, Sievenpiper JL, Vuksan V. Co-administration of viscous fiber, Salba-chia and ginseng on glycemic management in type 2 diabetes: a double-blind randomized controlled trial. Eur J Nutr. 2021 Sep;60(6):3071-3083. doi: 10.1007/s00394-020-02434-7. Epub 2021 Jan 24. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Positive Control | Dietary Supplement | Oat bran blend and wheat bran capsules |
|
| Baseline to 24 weeks |
| Baseline to 24 weeks |
| Change in HOMA-IR | Assessed via laboratory analysis | Baseline to 24 weeks |
| Change in total cholesterol | Assessed via laboratory analysis | Baseline to 24 weeks |
| Change in triglycerides | Assessed via laboratory analysis | Baseline to 24 weeks |
| Change in HDL-C | Assessed via laboratory analysis | Baseline to 24 weeks |
| Change in total cholesterol:HDL-C | Assessed via laboratory analysis | Baseline to 24 weeks |
| Change in Non-HDL-C | Assessed via laboratory analysis | Baseline to 24 weeks |
| Change in Apo-B | Assessed via laboratory analysis | Baseline to 24 weeks |
| Change in 24h diastolic BP | Assessed via analysis | Baseline to 24 weeks |
| Change in office systolic BP | Assessed via analysis | Baseline to 24 weeks |
| Change in office diastolic BP | Assessed via analysis | Baseline to 24 weeks |
| Change in central systolic BP | Assessed via analysis | Baseline to 24 weeks |
| Change in central diastolic BP | Assessed via analysis | Baseline to 24 weeks |
| Change in Augmentation index at heart rate 75 bpm | Assessed via analysis | Baseline to 24 weeks |
| Change in Hs-CRP | Assessed via laboratory analysis | Baseline to 24 weeks |
| Zagreb |
| 10000 |
| Croatia |
| D004700 | Endocrine System Diseases |