Effectiveness and Safety of Salba on Weight Loss in Overweight Individuals With Type 2 Diabetes
- Conditions
- Diabetes MellitusObesityOverweight
- Interventions
- Dietary Supplement: Oat-based ControlDietary Supplement: Salba (Salvia hispanica L.)
- Registration Number
- NCT01403571
- Lead Sponsor
- Unity Health Toronto
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 77
- Well-controlled type 2 diabetes for at least 1 year
- Treated with diet and/or oral hypoglycemic medications
- BMI 25-40 kg/m2
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oat-bran based Control Supplement Oat-based Control 36g/1000kcal Salba supplement Salba (Salvia hispanica L.) 30g/1000kal
- Primary Outcome Measures
Name Time Method Weight 24 weeks 24 week timeframe for Weightloss phase
- Secondary Outcome Measures
Name Time Method Body composition 24 weeks 24 week timeframe for Weightloss phase
Low grade body inflammation 24 weeks hs-CRP levels
Satiety hormones 24 weeks ghrelin, adiponectin
serum ALT 24 weeks Safety Measures
serum creatinine 24 weeks Safety Measures
Blood urea 24 weeks Safety Measures
Fatty Acids (% composition) 24 weeks ALA (18:3 n-3), LA (18:2 n-6); Compliance measure
Blood sugar control 24 weeks (HbA1c and Fasting glucose) 24 week timeframe for Weightloss phase
Prothrombin time 24 weeks Safety Measures
Trial Locations
- Locations (1)
Risk Factor Modification Centre, St. Michael's
🇨🇦Toronto, Ontario, Canada