Fibre Grain Herb Trial in Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: Dietary, Herbal; Dietary Supplement: Positive Control

• Registration Number: NCT02553382
• Lead Sponsor: Unity Health Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-30
• Study First Submitted QC: 2015-09-16
• Study First Posted: 2015-09-17
• Study Start: 2015-11
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-21
• Last Update Posted: 2020-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary, Herbal	Dietary, Herbal	-
Positive Control	Positive Control	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	Baseline to 24 weeks	Assessed via laboratory analysis

Secondary Outcome Measures

Name	Time	Method
Change in LDL-C	Baseline to 24 weeks	Assessed via laboratory analysis
Change in 24h ambulatory systolic blood pressure	Baseline to 24 weeks	Assessed via analysis

Trial Locations

Locations (2)

St. Michael's Hopsital; 🇨🇦 Toronto, Ontario, Canada

Clinical Centre Vuk Vrhovac, Merkur Hospital; 🇭🇷 Zagreb, Croatia