Fibre Grain Herb Trial in Type 2 Diabetes
FIGHT
Co-administration of Three Complimentary Therapies (Viscous Dietary Fiber, Whole Grain and Ginseng) for Comprehensive Risk Reduction in Type 2 Diabetes Mellitus
1 other identifier
interventional
104
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Nov 2015
Typical duration for not_applicable type-2-diabetes
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2015
CompletedFirst Posted
Study publicly available on registry
September 17, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedMay 26, 2020
May 1, 2020
2.4 years
July 30, 2015
May 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c
Assessed via laboratory analysis
Baseline to 24 weeks
Secondary Outcomes (2)
Change in LDL-C
Baseline to 24 weeks
Change in 24h ambulatory systolic blood pressure
Baseline to 24 weeks
Other Outcomes (16)
Change in fasting glucose
Baseline to 24 weeks
Change in fasting insulin
Baseline to 24 weeks
Change in HOMA-IR
Baseline to 24 weeks
- +13 more other outcomes
Study Arms (2)
Dietary, Herbal
EXPERIMENTALPositive Control
PLACEBO COMPARATORInterventions
Viscous fibre blend and Salba and American and Korean Red Ginseng capsules
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Unity Health Torontolead
- Canadian Diabetes Associationcollaborator
Study Sites (2)
St. Michael's Hopsital
Toronto, Ontario, M5B 1M4, Canada
Clinical Centre Vuk Vrhovac, Merkur Hospital
Zagreb, 10000, Croatia
Related Publications (1)
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.
PMID: 33486572DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2015
First Posted
September 17, 2015
Study Start
November 1, 2015
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
May 26, 2020
Record last verified: 2020-05