An interventional study of Dietary, Herbal and Positive Control in Type 2 Diabetes, sponsored by Unity Health Toronto. Completed at 2 sites in 2 countries. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-05-26.
Sponsored by Unity Health Toronto · Not applicable, Interventional, and Treatment
Despite the availability of multiple medications for the treatment of Type 2 diabetes, patients often continue to have difficulty attaining blood glucose targets and managing cardiovascular disease risk factors. Recent trends in non-pharmacological therapy have created a growing public interest in dietary supplements.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 104 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dietary Supplement: Dietary, Herbal
Dietary Supplement: Positive Control
Viscous fibre blend and Salba and American and Korean Red Ginseng capsules
Oat bran blend and wheat bran capsules
Change in HbA1c
Assessed via laboratory analysis
Time frame: Baseline to 24 weeks
Change in LDL-C
Assessed via laboratory analysis
Time frame: Baseline to 24 weeks
Change in 24h ambulatory systolic blood pressure
Assessed via analysis
Time frame: Baseline to 24 weeks
Change in fasting glucose
Assessed via laboratory analysis
Time frame: Baseline to 24 weeks
Change in fasting insulin
Assessed via laboratory analysis
Time frame: Baseline to 24 weeks
Change in HOMA-IR
Assessed via laboratory analysis
Time frame: Baseline to 24 weeks
Change in total cholesterol
Assessed via laboratory analysis
Time frame: Baseline to 24 weeks
Change in triglycerides
Assessed via laboratory analysis
Time frame: Baseline to 24 weeks
Change in HDL-C
Assessed via laboratory analysis
Time frame: Baseline to 24 weeks
Change in total cholesterol:HDL-C
Assessed via laboratory analysis
Time frame: Baseline to 24 weeks
Change in Non-HDL-C
Assessed via laboratory analysis
Time frame: Baseline to 24 weeks
Change in Apo-B
Assessed via laboratory analysis
Time frame: Baseline to 24 weeks
Change in 24h diastolic BP
Assessed via analysis
Time frame: Baseline to 24 weeks
Change in office systolic BP
Assessed via analysis
Time frame: Baseline to 24 weeks
Change in office diastolic BP
Assessed via analysis
Time frame: Baseline to 24 weeks
Change in central systolic BP
Assessed via analysis
Time frame: Baseline to 24 weeks
Change in central diastolic BP
Assessed via analysis
Time frame: Baseline to 24 weeks
Change in Augmentation index at heart rate 75 bpm
Assessed via analysis
Time frame: Baseline to 24 weeks
Change in Hs-CRP
Assessed via laboratory analysis
Time frame: Baseline to 24 weeks
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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