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| Name | Class |
|---|---|
| Canadian Diabetes Association | OTHER |
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Canadian statistics indicate that the incidence of obesity is increasing and that the occurrence of diabetes in obese individuals is 5-fold greater than those with a healthy weight, making weight control in this population particularly relevant. Preliminary clinical data has shown that the whole grain, Salba, may improve type 2 diabetes control, reduce after-meal blood glucose, cardiovascular disease (CVD) risk factors and suppress appetite. Its use may therefore have potential implications in long-term weight management, while improving diabetes.
The objective of this research (weight loss) is to evaluate whether adding Salba to an energy reduced diet for six months will result in greater weight loss compared to control in overweight and obese individuals with type 2 diabetes. The study recruited 77 overweight or obese individuals with type 2 diabetes. They were instructed to follow a calorie restricted diet and their regular diabetes therapy together with regular exercise. Participants were randomly assigned to receive 30 g Salba/1000 kcal of daily energy requirements, or an oat bran control supplement matched for energy. The effect of the supplements on weight-loss (including waist circumference, % body fat) and glucose control (A1c, fasting glucose levels) will be assessed. In addition, related outcomes such as low-grade body inflammation, hunger-regulating hormones (ghrelin, adiponectin), safety measures (urea, creatinine, ALT and prothrombin time) and satiety scores were evaluated.
Modest weight loss has been associated with improved glucose control in individuals with type 2 diabetes. Addition of Salba to an energy reduced diet may facilitate greater weight loss and improve glycemic control and CVD risk factors compared to such a diet alone. Salba may also promote maintenance of weight loss and therefore help prevent weight gain by providing feelings of fullness that reduce appetite. In light of the high incidence of obesity in individuals with diabetes, Salba grain may be a useful addition to the diet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salba supplement | Experimental | 30g/1000kal |
|
| Oat-bran based Control Supplement | Placebo Comparator | 36g/1000kcal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salba (Salvia hispanica L.) | Dietary Supplement | 30g/1000kcal/day over 24 wks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | 24 week timeframe for Weightloss phase | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | 24 week timeframe for Weightloss phase | 24 weeks |
| Blood sugar control | (HbA1c and Fasting glucose) 24 week timeframe for Weightloss phase |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Risk Factor Modification Centre, St. Michael's | Toronto | Ontario | M5B1W8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28089080 | Derived | Vuksan V, Jenkins AL, Brissette C, Choleva L, Jovanovski E, Gibbs AL, Bazinet RP, Au-Yeung F, Zurbau A, Ho HV, Duvnjak L, Sievenpiper JL, Josse RG, Hanna A. Salba-chia (Salvia hispanica L.) in the treatment of overweight and obese patients with type 2 diabetes: A double-blind randomized controlled trial. Nutr Metab Cardiovasc Dis. 2017 Feb;27(2):138-146. doi: 10.1016/j.numecd.2016.11.124. Epub 2016 Dec 9. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Oat-based Control |
| Dietary Supplement |
Placebo: 36g/1000kcal/day over 24 weeks |
|
| 24 weeks |
| Low grade body inflammation | hs-CRP levels | 24 weeks |
| serum ALT | Safety Measures | 24 weeks |
| Prothrombin time | Safety Measures | 24 weeks |
| serum creatinine | Safety Measures | 24 weeks |
| Blood urea | Safety Measures | 24 weeks |
| Satiety hormones | ghrelin, adiponectin | 24 weeks |
| Fatty Acids (% composition) | ALA (18:3 n-3), LA (18:2 n-6); Compliance measure | 24 weeks |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |