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Effectiveness and Safety of Salba on Weight Loss in Overweight Individuals With Type 2 Diabetes (LOSS)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Diabetes Mellitus Overweight Obesity | Dietary Supplement: Salba (Salvia hispanica L.) Dietary Supplement: Oat-based Control | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of Whole Grain Salba (Salvia Hispanica L.) on Weight Loss in Overweight and Obese Individuals With Type 2 Diabetes |
- Weight [ Time Frame: 24 weeks ]24 week timeframe for Weightloss phase
- Body composition [ Time Frame: 24 weeks ]24 week timeframe for Weightloss phase
- Blood sugar control [ Time Frame: 24 weeks ](HbA1c and Fasting glucose) 24 week timeframe for Weightloss phase
- Low grade body inflammation [ Time Frame: 24 weeks ]hs-CRP levels
- serum ALT [ Time Frame: 24 weeks ]Safety Measures
- Prothrombin time [ Time Frame: 24 weeks ]Safety Measures
- serum creatinine [ Time Frame: 24 weeks ]Safety Measures
- Blood urea [ Time Frame: 24 weeks ]Safety Measures
- Satiety hormones [ Time Frame: 24 weeks ]ghrelin, adiponectin
- Fatty Acids (% composition) [ Time Frame: 24 weeks ]ALA (18:3 n-3), LA (18:2 n-6); Compliance measure
| Enrollment: | 77 |
| Study Start Date: | October 2009 |
| Study Completion Date: | August 2015 |
| Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Salba supplement
30g/1000kal
|
Dietary Supplement: Salba (Salvia hispanica L.)
30g/1000kcal/day over 24 wks
|
|
Placebo Comparator: Oat-bran based Control Supplement
36g/1000kcal
|
Dietary Supplement: Oat-based Control
Placebo: 36g/1000kcal/day over 24 weeks
|
Eligibility| Ages Eligible for Study: | 35 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01403571
| Canada, Ontario | |
| Risk Factor Modification Centre, St. Michael's | |
| Toronto, Ontario, Canada, M5B1W8 | |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | St. Michael's Hospital, Toronto |
| ClinicalTrials.gov Identifier: | NCT01403571 History of Changes |
| Other Study ID Numbers: |
2103038AJ |
| Study First Received: | July 25, 2011 |
| Last Updated: | October 4, 2016 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Overweight Weight Loss Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Body Weight Signs and Symptoms Body Weight Changes |
ClinicalTrials.gov processed this record on June 23, 2017