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

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ClinicalTrials.gov Identifier: NCT01403571
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : October 5, 2016
Sponsor:
Collaborator:
Canadian Diabetes Association
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Study Description
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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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Overweight Obesity Dietary Supplement: Salba (Salvia hispanica L.) Dietary Supplement: Oat-based Control Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : October 2009
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Salvia

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Weight [ Time Frame: 24 weeks ]
    24 week timeframe for Weightloss phase


Secondary Outcome Measures :
  1. Body composition [ Time Frame: 24 weeks ]
    24 week timeframe for Weightloss phase

  2. Blood sugar control [ Time Frame: 24 weeks ]
    (HbA1c and Fasting glucose) 24 week timeframe for Weightloss phase

  3. Low grade body inflammation [ Time Frame: 24 weeks ]
    hs-CRP levels

  4. serum ALT [ Time Frame: 24 weeks ]
    Safety Measures

  5. Prothrombin time [ Time Frame: 24 weeks ]
    Safety Measures

  6. serum creatinine [ Time Frame: 24 weeks ]
    Safety Measures

  7. Blood urea [ Time Frame: 24 weeks ]
    Safety Measures

  8. Satiety hormones [ Time Frame: 24 weeks ]
    ghrelin, adiponectin

  9. Fatty Acids (% composition) [ Time Frame: 24 weeks ]
    ALA (18:3 n-3), LA (18:2 n-6); Compliance measure


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01403571


Locations
Canada, Ontario
Risk Factor Modification Centre, St. Michael's
Toronto, Ontario, Canada, M5B1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Canadian Diabetes Association
More Information
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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
First Posted: July 27, 2011    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 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