Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
104 participants
INTERVENTIONAL
2015-11-30
2018-04-30
Brief Summary
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Research by this group and others support the benefits of whole grains, viscous dietary fibre and ginseng in the management of diabetes. The current study investigates whether the co-administration of a viscous dietary fibre blend, Salba (a grain rich in omega-3 fatty acids), and 2 varieties of ginseng roots will further improve blood sugar control and cardiovascular disease risk outcomes in individuals with Type 2 diabetes already receiving conventional treatments.
Patients with Type 2 diabetes receiving the recommended intervention in accordance with the Canadian Diabetes Association guidelines will be enrolled in a 6-month clinical study. Half of the participants will be randomly assigned to a 4-component intervention that comprises the co-administration of these four dietary/herbal supplements in addition to their usual treatment regimen; the other half will continue their usual treatment regimen in addition to taking high-oat fiber and wheat bran supplements.
The investigators hypothesize that an intensified, multi-targeted intervention with the addition of these dietary and herb components will further improve long-term blood glucose control and cardiovascular disease risk factors beyond conventional therapy. If this combination of viscous fiber, Salba and ginseng is shown to be beneficial, these remedies could complement current conventional therapy for Type 2 diabetes with the goal to further improve health outcomes.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dietary, Herbal
Dietary, Herbal
Viscous fibre blend and Salba and American and Korean Red Ginseng capsules
Positive Control
Positive Control
Oat bran blend and wheat bran capsules
Interventions
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Dietary, Herbal
Viscous fibre blend and Salba and American and Korean Red Ginseng capsules
Positive Control
Oat bran blend and wheat bran capsules
Eligibility Criteria
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Inclusion Criteria
* HbA1c (glycated hemoglobin) between 6.3% and 8.5% at screening
* BMI \< 35 kg/m2
Exclusion Criteria
* Blood pressure ≥ 160/100 mmHg
* Serum triglyceride \>4.5mmol/L
* History of major cardiovascular events (stroke or myocardial infarction)
* Gastrointestinal, liver or kidney disease
* Consumption of alcohol \>2 drinks/day
* Current tobacco smokers
* Taking the following medications: herbs or supplements that may affect primary or secondary outcomes, monoamine oxidase inhibitors (MAOIs) antidepressants and/or anticoagulant therapy
* Women with hormone sensitive tumors/conditions
40 Years
75 Years
ALL
No
Sponsors
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Canadian Diabetes Association
OTHER
Unity Health Toronto
OTHER
Responsible Party
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Locations
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St. Michael's Hopsital
Toronto, Ontario, Canada
Clinical Centre Vuk Vrhovac, Merkur Hospital
Zagreb, , Croatia
Countries
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References
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Zurbau A, Smircic Duvnjak L, Magas S, Jovanovski E, Miocic J, Jenkins AL, Jenkins DJA, Josse RG, Leiter LA, Sievenpiper JL, Vuksan V. Co-administration of viscous fiber, Salba-chia and ginseng on glycemic management in type 2 diabetes: a double-blind randomized controlled trial. Eur J Nutr. 2021 Sep;60(6):3071-3083. doi: 10.1007/s00394-020-02434-7. Epub 2021 Jan 24.
Other Identifiers
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15-111
Identifier Type: -
Identifier Source: org_study_id
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