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

Unity Health Toronto

Status and phase

Completed

Phase 2

Conditions

Overweight

Diabetes Mellitus

Obesity

Treatments

Dietary Supplement: Salba (Salvia hispanica L.)

Dietary Supplement: Oat-based Control

Study type

Interventional

Funder types

Other

Identifiers

NCT01403571

2103038AJ

Details and patient eligibility

About

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.

Enrollment

77 patients

Sex

All

Ages

35 to 75 years old

Volunteers

Accepts Healthy Volunteers

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