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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: Dietary, Herbal; Dietary supplement: Positive Control

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1M4
      • St. Michael's Hopsital
• Croatia
  • Zagreb, Croatia, 10000
    • Clinical Centre Vuk Vrhovac, Merkur Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c	Assessed via laboratory analysis	Baseline to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in LDL-C	Assessed via laboratory analysis	Baseline to 24 weeks
Change in 24h ambulatory systolic blood pressure	Assessed via analysis	Baseline to 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fasting glucose	Assessed via laboratory analysis	Baseline to 24 weeks
Change in fasting insulin	Assessed via laboratory analysis	Baseline to 24 weeks
Change in HOMA-IR	Assessed via laboratory analysis	Baseline to 24 weeks
Change in total cholesterol	Assessed via laboratory analysis	Baseline to 24 weeks
Change in triglycerides	Assessed via laboratory analysis	Baseline to 24 weeks
Change in HDL-C	Assessed via laboratory analysis	Baseline to 24 weeks
Change in total cholesterol:HDL-C	Assessed via laboratory analysis	Baseline to 24 weeks
Change in Non-HDL-C	Assessed via laboratory analysis	Baseline to 24 weeks
Change in Apo-B	Assessed via laboratory analysis	Baseline to 24 weeks
Change in 24h diastolic BP	Assessed via analysis	Baseline to 24 weeks
Change in office systolic BP	Assessed via analysis	Baseline to 24 weeks
Change in office diastolic BP	Assessed via analysis	Baseline to 24 weeks
Change in central systolic BP	Assessed via analysis	Baseline to 24 weeks
Change in central diastolic BP	Assessed via analysis	Baseline to 24 weeks
Change in Augmentation index at heart rate 75 bpm	Assessed via analysis	Baseline to 24 weeks
Change in Hs-CRP	Assessed via laboratory analysis	Baseline to 24 weeks

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Collaborators: Canadian Diabetes Association

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: July 30, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (Estimate): September 17, 2015

Study Record Updates

• Last Update Posted (Actual): May 26, 2020
• Last Update Submitted That Met QC Criteria: May 21, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 15-111