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NCT Number: NCT02553382

Fibre Grain Herb Trial in Type 2 Diabetes

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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hopsital, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary, Herbal

Dietary Supplement

Viscous fibre blend and Salba and American and Korean Red Ginseng capsules

Positive Control

Dietary Supplement

Oat bran blend and wheat bran capsules

Primary outcomes

  1. Change in HbA1c

    Time frame: Baseline to 24 weeks

    Assessed via laboratory analysis

Secondary outcomes

  1. Change in LDL-C

    Time frame: Baseline to 24 weeks

    Assessed via laboratory analysis

  2. Change in 24h ambulatory systolic blood pressure

    Time frame: Baseline to 24 weeks

    Assessed via analysis

Other outcomes

  1. Change in fasting glucose

    Time frame: Baseline to 24 weeks

    Assessed via laboratory analysis

  2. Change in fasting insulin

    Time frame: Baseline to 24 weeks

    Assessed via laboratory analysis

  3. Change in HOMA-IR

    Time frame: Baseline to 24 weeks

    Assessed via laboratory analysis

  4. Change in total cholesterol

    Time frame: Baseline to 24 weeks

    Assessed via laboratory analysis

  5. Change in triglycerides

    Time frame: Baseline to 24 weeks

    Assessed via laboratory analysis

  6. Change in HDL-C

    Time frame: Baseline to 24 weeks

    Assessed via laboratory analysis

  7. Change in total cholesterol:HDL-C

    Time frame: Baseline to 24 weeks

    Assessed via laboratory analysis

  8. Change in Non-HDL-C

    Time frame: Baseline to 24 weeks

    Assessed via laboratory analysis

  9. Change in Apo-B

    Time frame: Baseline to 24 weeks

    Assessed via laboratory analysis

  10. Change in 24h diastolic BP

    Time frame: Baseline to 24 weeks

    Assessed via analysis

  11. Change in office systolic BP

    Time frame: Baseline to 24 weeks

    Assessed via analysis

  12. Change in office diastolic BP

    Time frame: Baseline to 24 weeks

    Assessed via analysis

  13. Change in central systolic BP

    Time frame: Baseline to 24 weeks

    Assessed via analysis

  14. Change in central diastolic BP

    Time frame: Baseline to 24 weeks

    Assessed via analysis

  15. Change in Augmentation index at heart rate 75 bpm

    Time frame: Baseline to 24 weeks

    Assessed via analysis

  16. Change in Hs-CRP

    Time frame: Baseline to 24 weeks

    Assessed via laboratory analysis

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • Canadian Diabetes Association

Registry information

Official study title

Co-administration of Three Complimentary Therapies (Viscous Dietary Fiber, Whole Grain and Ginseng) for Comprehensive Risk Reduction in Type 2 Diabetes Mellitus

Acronym: FIGHT

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 17, 2015
Registry last updated
May 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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