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The purpose of this study is to determine whether the addition of Salvia hispanica L. Alba (Salba) to the conventional treatment for diabetes is associated with improvement in major and emerging cardiovascular risk factors in people with type 2 diabetes.
Cohort studies have linked consumption of whole grain with a reduction in the risk of developing diabetes and heart disease. Grain of the plant Salvia hispanica alba (Salba) contain a high concentration of ω-3 fatty acids in addition to being a rich source of vegetable protein, fiber, calcium and antioxidants which have cardiovascular protective effect. To address the paucity of randomized, well-controlled clinical studies supporting the long-term cardioprotective benefits of whole grain we investigated the effects of a novel grain Salba in type 2 diabetes.
Comparison(s): Participants on a conventional diabetes diet (50% carbohydrate, 20% protein, 30% fat) receive either addition of Salba or matched control supplement for 12 weeks separated by a 4-week washout period.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salba diet | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - major and emerging risk factors for cardiovascular disease (blood pressure, Hs-C-reactive protein, coagulation factors) | ||
| safety (liver, kidney and haemostatic function) | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir Vuksan, PhD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Toronto | Ontario | M5C2T2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17686832 | Derived | Vuksan V, Whitham D, Sievenpiper JL, Jenkins AL, Rogovik AL, Bazinet RP, Vidgen E, Hanna A. Supplementation of conventional therapy with the novel grain Salba (Salvia hispanica L.) improves major and emerging cardiovascular risk factors in type 2 diabetes: results of a randomized controlled trial. Diabetes Care. 2007 Nov;30(11):2804-10. doi: 10.2337/dc07-1144. Epub 2007 Aug 8. |
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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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| compliance (plasma fatty-acids, returned supplements, diet records, body weight). |
| D004700 | Endocrine System Diseases |