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NCT Number: NCT01403571

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

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.

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Key information

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Risk Factor Modification Centre, St. Michael's

Toronto, Ontario, M5B1W8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salba (Salvia hispanica L.)

Dietary Supplement

30g/1000kcal/day over 24 wks

Oat-based Control

Dietary Supplement

Placebo: 36g/1000kcal/day over 24 weeks

Primary outcomes

  1. Weight

    Time frame: 24 weeks

    24 week timeframe for Weightloss phase

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • Canadian Diabetes Association

Registry information

Official study title

Efficacy and Safety of Whole Grain Salba (Salvia Hispanica L.) on Weight Loss in Overweight and Obese Individuals With Type 2 Diabetes

Acronym: LOSS

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Jul 27, 2011
Registry last updated
Oct 5, 2016

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.

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