Risk Factor Modification Centre, St. Michael's
Toronto, Ontario, M5B1W8, Canada
NCT Number: NCT01403571
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.
Looking for future studies?
Notify Me35 year–75 year
All sexes
Interventional
Phase 2
Toronto, Ontario, M5B1W8, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
30g/1000kcal/day over 24 wks
Placebo: 36g/1000kcal/day over 24 weeks
Time frame: 24 weeks
24 week timeframe for Weightloss phase
Time frame: 24 weeks
24 week timeframe for Weightloss phase
Time frame: 24 weeks
(HbA1c and Fasting glucose) 24 week timeframe for Weightloss phase
Time frame: 24 weeks
hs-CRP levels
Time frame: 24 weeks
Safety Measures
Time frame: 24 weeks
Safety Measures
Time frame: 24 weeks
Safety Measures
Time frame: 24 weeks
Safety Measures
Time frame: 24 weeks
ghrelin, adiponectin
Time frame: 24 weeks
ALA (18:3 n-3), LA (18:2 n-6); Compliance measure
Unity Health Toronto
Other
Efficacy and Safety of Whole Grain Salba (Salvia Hispanica L.) on Weight Loss in Overweight and Obese Individuals With Type 2 Diabetes
Acronym: LOSS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05144737
Body Weight, Cardiovascular Diseases
Baltimore, Maryland, United States
View Trial DetailsNCT02991534
Body Weight, Cardiovascular Diseases
Sepulveda, California, United States
View Trial DetailsNCT04507867
Body Weight, COVID-19
Toluca, State of Mexico, Mexico
View Trial DetailsNCT03645382
Body Weight, Diabetes Mellitus
Seoul, South Korea
View Trial Details