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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01403571
Acronym
LOSS
Enrollment
77
Registered
2011-07-27
Start date
2009-10-31
Completion date
2015-08-31
Last updated
2016-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Obesity, Overweight

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.

Interventions

DIETARY_SUPPLEMENTSalba (Salvia hispanica L.)

30g/1000kcal/day over 24 wks

DIETARY_SUPPLEMENTOat-based Control

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

Sponsors

Canadian Diabetes Association
CollaboratorOTHER
Unity Health Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Weight24 weeks24 week timeframe for Weightloss phase

Secondary

MeasureTime frameDescription
Blood sugar control24 weeks(HbA1c and Fasting glucose) 24 week timeframe for Weightloss phase
Low grade body inflammation24 weekshs-CRP levels
serum ALT24 weeksSafety Measures
Prothrombin time24 weeksSafety Measures
Body composition24 weeks24 week timeframe for Weightloss phase
Blood urea24 weeksSafety Measures
Satiety hormones24 weeksghrelin, adiponectin
Fatty Acids (% composition)24 weeksALA (18:3 n-3), LA (18:2 n-6); Compliance measure
serum creatinine24 weeksSafety Measures

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026