Clinical trial NCT01403571: Effectiveness and Safety of Salba on Weight Loss in Overweight Individuals With Type 2 Diabetes
Official title: Efficacy and Safety of Whole Grain Salba (Salvia Hispanica L.) on Weight Loss in Overweight and Obese Individuals With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus
Overweight
Obesity
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Diabetes Association
First posted: 2011-07-27
Enrollment: 77
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Weight
timeFrame: 24 weeks
Secondary outcomes:
measure: Body composition
timeFrame: 24 weeks
measure: Blood sugar control
timeFrame: 24 weeks
measure: Low grade body inflammation
timeFrame: 24 weeks
measure: serum ALT
timeFrame: 24 weeks
measure: Prothrombin time
timeFrame: 24 weeks
measure: serum creatinine
timeFrame: 24 weeks
measure: Blood urea
timeFrame: 24 weeks
measure: Satiety hormones
timeFrame: 24 weeks
measure: Fatty Acids (% composition)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Risk Factor Modification Centre, St. Michael's
state: Ontario
Study officials:
References:
citation: 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.