Clinical trial NCT02553382: Fibre Grain Herb Trial in Type 2 Diabetes
Official title: Co-administration of Three Complimentary Therapies (Viscous Dietary Fiber, Whole Grain and Ginseng) for Comprehensive Risk Reduction in Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Diabetes Association
First posted: 2015-09-17
Enrollment: 104
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in HbA1c
timeFrame: Baseline to 24 weeks
Secondary outcomes:
measure: Change in LDL-C
timeFrame: Baseline to 24 weeks
measure: Change in 24h ambulatory systolic blood pressure
timeFrame: Baseline to 24 weeks
Other outcomes:
measure: Change in fasting glucose
timeFrame: Baseline to 24 weeks
measure: Change in fasting insulin
timeFrame: Baseline to 24 weeks
measure: Change in HOMA-IR
timeFrame: Baseline to 24 weeks
measure: Change in total cholesterol
timeFrame: Baseline to 24 weeks
measure: Change in triglycerides
timeFrame: Baseline to 24 weeks
measure: Change in HDL-C
timeFrame: Baseline to 24 weeks
measure: Change in total cholesterol:HDL-C
timeFrame: Baseline to 24 weeks
measure: Change in Non-HDL-C
timeFrame: Baseline to 24 weeks
measure: Change in Apo-B
timeFrame: Baseline to 24 weeks
measure: Change in 24h diastolic BP
timeFrame: Baseline to 24 weeks
measure: Change in office systolic BP
timeFrame: Baseline to 24 weeks
measure: Change in office diastolic BP
timeFrame: Baseline to 24 weeks
measure: Change in central systolic BP
timeFrame: Baseline to 24 weeks
measure: Change in central diastolic BP
timeFrame: Baseline to 24 weeks
measure: Change in Augmentation index at heart rate 75 bpm
timeFrame: Baseline to 24 weeks
measure: Change in Hs-CRP
timeFrame: Baseline to 24 weeks
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hopsital
state: Ontario
city: Zagreb
country: Croatia
facility: Clinical Centre Vuk Vrhovac, Merkur Hospital
Study officials:
References:
citation: 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.