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临床试验/NCT02553382
NCT02553382已完成不适用

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

Unity Health Toronto4 个研究点 分布在 2 个国家目标入组 104 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
104
试验地点
4
主要终点
Change in HbA1c

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change in HbA1c

时间窗: Baseline to 24 weeks

Assessed via laboratory analysis

次要结局

  • Change in LDL-C(Baseline to 24 weeks)
  • Change in 24h ambulatory systolic blood pressure(Baseline to 24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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