Fibre Grain Herb Trial in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— FIGHT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02553382
• Other study ID #: 15-111
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: April 2018

Study information

• Verified date: May 2020
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Dietary, Herbal
Viscous fibre blend and Salba and American and Korean Red Ginseng capsules
• Positive Control
Oat bran blend and wheat bran capsules

Locations

Country	Name	City	State
Canada	St. Michael's Hopsital	Toronto	Ontario
Croatia	Clinical Centre Vuk Vrhovac, Merkur Hospital	Zagreb

Sponsors (2)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Canadian Diabetes Association

Countries where clinical trial is conducted

Canada,  Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in fasting glucose	Assessed via laboratory analysis	Baseline to 24 weeks
Other	Change in fasting insulin	Assessed via laboratory analysis	Baseline to 24 weeks
Other	Change in HOMA-IR	Assessed via laboratory analysis	Baseline to 24 weeks
Other	Change in total cholesterol	Assessed via laboratory analysis	Baseline to 24 weeks
Other	Change in triglycerides	Assessed via laboratory analysis	Baseline to 24 weeks
Other	Change in HDL-C	Assessed via laboratory analysis	Baseline to 24 weeks
Other	Change in total cholesterol:HDL-C	Assessed via laboratory analysis	Baseline to 24 weeks
Other	Change in Non-HDL-C	Assessed via laboratory analysis	Baseline to 24 weeks
Other	Change in Apo-B	Assessed via laboratory analysis	Baseline to 24 weeks
Other	Change in 24h diastolic BP	Assessed via analysis	Baseline to 24 weeks
Other	Change in office systolic BP	Assessed via analysis	Baseline to 24 weeks
Other	Change in office diastolic BP	Assessed via analysis	Baseline to 24 weeks
Other	Change in central systolic BP	Assessed via analysis	Baseline to 24 weeks
Other	Change in central diastolic BP	Assessed via analysis	Baseline to 24 weeks
Other	Change in Augmentation index at heart rate 75 bpm	Assessed via analysis	Baseline to 24 weeks
Other	Change in Hs-CRP	Assessed via laboratory analysis	Baseline to 24 weeks
Primary	Change in HbA1c	Assessed via laboratory analysis	Baseline to 24 weeks
Secondary	Change in LDL-C	Assessed via laboratory analysis	Baseline to 24 weeks
Secondary	Change in 24h ambulatory systolic blood pressure	Assessed via analysis	Baseline to 24 weeks