NCT01403571

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetes Mellitus
• Overweight
• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Salba (Salvia hispanica L.)	30g/1000kcal/day over 24 wks
DIETARY_SUPPLEMENT	Oat-based Control	Placebo: 36g/1000kcal/day over 24 weeks

Timeline

• Start date: 2009-10-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2011-07-27
• Last updated: 2016-10-05

Locations

1 site across 1 country: Canada