Type 2 Diabetes
Conditions
Brief summary
The purpose of this study is to determine whether the addition of Salvia hispanica L. Alba (Salba) to the conventional treatment for diabetes is associated with improvement in major and emerging cardiovascular risk factors in people with type 2 diabetes.
Detailed description
Cohort studies have linked consumption of whole grain with a reduction in the risk of developing diabetes and heart disease. Grain of the plant Salvia hispanica alba (Salba) contain a high concentration of ω-3 fatty acids in addition to being a rich source of vegetable protein, fiber, calcium and antioxidants which have cardiovascular protective effect. To address the paucity of randomized, well-controlled clinical studies supporting the long-term cardioprotective benefits of whole grain we investigated the effects of a novel grain Salba in type 2 diabetes. Comparison(s): Participants on a conventional diabetes diet (50% carbohydrate, 20% protein, 30% fat) receive either addition of Salba or matched control supplement for 12 weeks separated by a 4-week washout period.
Interventions
BEHAVIORALSalba diet
Sponsors
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Inclusion criteria
* All men or postmenopausal women with Type 2 diabetes optimally or suboptimally controlled (HbA1C \< 9.0%) on oral hypoglycemic agents or diet only were asked to participate.
Exclusion criteria
* Those receiving insulin, alpha-glucosidase inhibitors, or hormone replacement therapy, with BMI\>38 kg/m2, smoking or significant alcohol intake (\>2 drinks/day), serum TG \>4.0 mmol/L, and those with complications of diabetes were excluded. Subjects were also excluded if they regularly took fish oil and flax seed supplements or used steroids. Subjects were excluded during the course of the study if there were any changes to their regular antihypertensive, lipid, or oral hypoglycemic medications, if unable to consume \>50% of supplements provided, had a significant weight change (defined as \>2.5 kg), or if their level of physical activity did not remain constant over the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy - major and emerging risk factors for cardiovascular disease (blood pressure, Hs-C-reactive protein, coagulation factors) | — |
| safety (liver, kidney and haemostatic function) | — |
| compliance (plasma fatty-acids, returned supplements, diet records, body weight). | — |
Countries
Canada
Outcome results
None listed