Effectiveness and Safety of Salba on Weight Loss in Overweight Individuals With Type 2 Diabetes (LOSS)
Primary Purpose
Diabetes Mellitus, Overweight, Obesity
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Salba (Salvia hispanica L.)
Oat-based Control
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus
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
Sites / Locations
- Risk Factor Modification Centre, St. Michael's
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Salba supplement
Oat-bran based Control Supplement
Arm Description
30g/1000kal
36g/1000kcal
Outcomes
Primary Outcome Measures
Weight
24 week timeframe for Weightloss phase
Secondary Outcome Measures
Body composition
24 week timeframe for Weightloss phase
Blood sugar control
(HbA1c and Fasting glucose) 24 week timeframe for Weightloss phase
Low grade body inflammation
hs-CRP levels
serum ALT
Safety Measures
Prothrombin time
Safety Measures
serum creatinine
Safety Measures
Blood urea
Safety Measures
Satiety hormones
ghrelin, adiponectin
Fatty Acids (% composition)
ALA (18:3 n-3), LA (18:2 n-6); Compliance measure
Full Information
NCT ID
NCT01403571
First Posted
July 25, 2011
Last Updated
October 4, 2016
Sponsor
Unity Health Toronto
Collaborators
Canadian Diabetes Association
1. Study Identification
Unique Protocol Identification Number
NCT01403571
Brief Title
Effectiveness and Safety of Salba on Weight Loss in Overweight Individuals With Type 2 Diabetes
Acronym
LOSS
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
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
Canadian Diabetes Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Overweight, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Salba supplement
Arm Type
Experimental
Arm Description
30g/1000kal
Arm Title
Oat-bran based Control Supplement
Arm Type
Placebo Comparator
Arm Description
36g/1000kcal
Intervention Type
Dietary Supplement
Intervention Name(s)
Salba (Salvia hispanica L.)
Intervention Description
30g/1000kcal/day over 24 wks
Intervention Type
Dietary Supplement
Intervention Name(s)
Oat-based Control
Intervention Description
Placebo: 36g/1000kcal/day over 24 weeks
Primary Outcome Measure Information:
Title
Weight
Description
24 week timeframe for Weightloss phase
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Body composition
Description
24 week timeframe for Weightloss phase
Time Frame
24 weeks
Title
Blood sugar control
Description
(HbA1c and Fasting glucose) 24 week timeframe for Weightloss phase
Time Frame
24 weeks
Title
Low grade body inflammation
Description
hs-CRP levels
Time Frame
24 weeks
Title
serum ALT
Description
Safety Measures
Time Frame
24 weeks
Title
Prothrombin time
Description
Safety Measures
Time Frame
24 weeks
Title
serum creatinine
Description
Safety Measures
Time Frame
24 weeks
Title
Blood urea
Description
Safety Measures
Time Frame
24 weeks
Title
Satiety hormones
Description
ghrelin, adiponectin
Time Frame
24 weeks
Title
Fatty Acids (% composition)
Description
ALA (18:3 n-3), LA (18:2 n-6); Compliance measure
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Risk Factor Modification Centre, St. Michael's
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1W8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
28089080
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.
Results Reference
derived
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Effectiveness and Safety of Salba on Weight Loss in Overweight Individuals With Type 2 Diabetes
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