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

This study has been completed.
Sponsor:
Collaborator:
Canadian Diabetes Association
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01403571
First received: July 25, 2011
Last updated: October 4, 2016
Last verified: October 2016
  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 (Subject, 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

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    24 week timeframe for Weightloss phase


Secondary Outcome Measures:
  • Body composition [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    24 week timeframe for Weightloss phase

  • Blood sugar control [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    (HbA1c and Fasting glucose) 24 week timeframe for Weightloss phase

  • Low grade body inflammation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    hs-CRP levels

  • serum ALT [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Safety Measures

  • Prothrombin time [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Safety Measures

  • serum creatinine [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Safety Measures

  • Blood urea [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Safety Measures

  • Satiety hormones [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    ghrelin, adiponectin

  • Fatty Acids (% composition) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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
Health Authority: Canada: Ethics Review Committee

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 December 02, 2016