Effectiveness and Safety of Salba on Weight Loss in Overweight Individuals With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Whole Grain Salba (Salvia Hispanica L.) on Weight Loss in Overweight and Obese Individuals With Type 2 Diabetes

Conditions
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Diabetes Mellitus, Overweight, Obesity

Intervention / Treatment
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* Dietary Supplement: Salba (Salvia hispanica L.)
* Dietary Supplement: Oat-based Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Well-controlled type 2 diabetes for at least 1 year Treated with diet and/or oral hypoglycemic medications BMI 25-40 kg/m2 Exclusion Criteria: Weight change in the past three months >10% of body weight On insulin therapy Unstable angina, myocardial infarction or stroke (within 6 months) Planned surgery or pregnancy Blood pressure >160mmHg/100mmHg Surgical procedures for weight loss and concomitant use of medication or supplements that alter body weight or appetite ALA, dietary fibre, fish oil supplements or consuming cold-water fish more than three times per week

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salba supplement<br>30g/1000kal | Dietary Supplement: Salba (Salvia hispanica L.)<br>* 30g/1000kcal/day over 24 wks<br>|
| Placebo Comparator: Oat-bran based Control Supplement<br>36g/1000kcal | Dietary Supplement: Oat-based Control<br>* Placebo: 36g/1000kcal/day over 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | 24 week timeframe for Weightloss phase | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |