FIGHT: Fibre Grain Herb Trial in Type 2 Diabetes
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dietary, Herbal
|
Dietary Supplement: Dietary, Herbal
Viscous fibre blend and Salba and American and Korean Red Ginseng capsules
|
| Placebo Comparator: Positive Control
|
Dietary Supplement: Positive Control
Oat bran blend and wheat bran capsules
|
Outcome Measures
Primary Outcome Measures
- Change in HbA1c [Baseline to 24 weeks]
Assessed via laboratory analysis
Secondary Outcome Measures
- Change in LDL-C [Baseline to 24 weeks]
Assessed via laboratory analysis
- Change in 24h ambulatory systolic blood pressure [Baseline to 24 weeks]
Assessed via analysis
Other Outcome Measures
- Change in fasting glucose [Baseline to 24 weeks]
Assessed via laboratory analysis
- Change in fasting insulin [Baseline to 24 weeks]
Assessed via laboratory analysis
- Change in HOMA-IR [Baseline to 24 weeks]
Assessed via laboratory analysis
- Change in total cholesterol [Baseline to 24 weeks]
Assessed via laboratory analysis
- Change in triglycerides [Baseline to 24 weeks]
Assessed via laboratory analysis
- Change in HDL-C [Baseline to 24 weeks]
Assessed via laboratory analysis
- Change in total cholesterol:HDL-C [Baseline to 24 weeks]
Assessed via laboratory analysis
- Change in Non-HDL-C [Baseline to 24 weeks]
Assessed via laboratory analysis
- Change in Apo-B [Baseline to 24 weeks]
Assessed via laboratory analysis
- Change in 24h diastolic BP [Baseline to 24 weeks]
Assessed via analysis
- Change in office systolic BP [Baseline to 24 weeks]
Assessed via analysis
- Change in office diastolic BP [Baseline to 24 weeks]
Assessed via analysis
- Change in central systolic BP [Baseline to 24 weeks]
Assessed via analysis
- Change in central diastolic BP [Baseline to 24 weeks]
Assessed via analysis
- Change in Augmentation index at heart rate 75 bpm [Baseline to 24 weeks]
Assessed via analysis
- Change in Hs-CRP [Baseline to 24 weeks]
Assessed via laboratory analysis
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Type 2 diabetes medically diagnosed for at least 6-months prior to randomization
-
HbA1c (glycated hemoglobin) between 6.3% and 8.5% at screening
-
BMI < 35 kg/m2
Exclusion Criteria:
-
Insulin therapy
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Michael's Hopsital | Toronto | Ontario | Canada | M5B 1M4 |
| 2 | Clinical Centre Vuk Vrhovac, Merkur Hospital | Zagreb | Croatia | 10000 |
Sponsors and Collaborators
- Unity Health Toronto
- Canadian Diabetes Association
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15-111