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临床试验/NCT02629952
NCT02629952Unknown不适用

Metabolic Benefits of Drinking Blueberry Tea in Type 2 Diabetes

Menzies Institute for Medical Research2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2015年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
36
试验地点
2
主要终点
Improvement in Glucose Tolerance after 4 weeks of drinking blueberry tea.

研究概览

简要总结

Plant derived compounds, e.g. flavonoids from dark chocolate, green tea, or blueberries, show great potential as nutraceuticals for the treatment of various diseases such as type 2 diabetes (T2D). Flavonoids have been suggested to improve glucose metabolism, reduce blood lipids, reduce oxidative stress and improve vascular function. For these reasons we recently investigated the effects of daily consumption of locally produced blueberry tea and demonstrated that this could partially restore insulin sensitivity in an animal model. We propose to translate these findings to assess the efficacy of this nutraceutical as a new treatment for improving glucose tolerance in people with T2D.

详细描述

Current treatments for T2D are limited, have unwanted side effects, and lose effectiveness over time. There is a growing public interest in the use of complementary and alternative approaches for treating insulin resistance and T2D. Blueberries, blueberry leaves and cinnamon have each been reported to improve insulin sensitivity or insulin action. Blueberry Boost™ is a locally produced Blueberry Tea and is a proprietary blend of dried blueberries (37% wt/wt), blueberry leaves, raspberry leaves, spearmint leaves and cinnamon.

It is well established that improving glycemic control is important for managing insulin resistance and T2D and the associated vascular pathologies that directly contribute to end-organ damage (microvascular disease), hypertension and cardiovascular disease (stroke, heart attack and heart failure). We have recently demonstrated that a unique blueberry tea blend fully restores the vascular insulin sensitivity in muscle of the high-fat fed insulin-resistant rat model and is associated with substantial improvements in muscle glucose uptake and whole body insulin sensitivity. We propose to translate these findings to assess the efficacy of this nutraceutical as a new treatment for improving glucose tolerance in people with T2D.

Aim: Determine whether chronic consumption (4 weeks) of blueberry tea can improve metabolic and vascular health in people with and without T2D.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Aged 18-75 years.
  • Normal to overweight (BMI 19-35 kg/m2).
  • On lifestyle or metformin only diabetes treatment.
  • Normotensive (seated brachial blood pressure <160/100 mmHg).
  • No history of T2D (e.g. fasting plasma glucose <7.0mM); or with clinically diagnosed T2D on metformin or lifestyle intervention only (e.g. fasting plasma glucose ≥7.0mM, HbA1c).
  • Willing to drink blueberry tea for 4 weeks (3 times per day with meals).

排除标准

  • Age <18 yrs or >76 yrs
  • Morbidly obese with a BMI ≥36 kg/m2
  • Not on lifestyle and/or metformin only treatment for diabetes (e.g. insulin injections, sulphonylureas).
  • History of myocardial infarction or stroke
  • History of malignancy within past 5 years (except for non-melanoma skin cancers)
  • Current smoker
  • History of severe liver disease
  • History of drug or alcohol abuse
  • Elective major surgery during the course of the study
  • Pregnancy/lactation
  • Currently consuming (or have regularly consumed in the past 2 months) blueberry tea, or supplements containing blueberries, blueberry leaves, raspberry leaves, spearmint or cinnamon.
  • Participation or intention to participate in another clinical research study during the study period.
  • Not willing to consume blueberry tea for 4 weeks.

结局指标

主要结局

Improvement in Glucose Tolerance after 4 weeks of drinking blueberry tea.

时间窗: 4 weeks

Oral glucose tolerance test (75g glucose) measured on 3 occasions: at baseline, after 4 weeks of drinking blueberry tea, and after 4 weeks of no treatment (randomized cross-over design). Blood glucose and plasma insulin levels measured at 0, 15, 30, 60, 90 and 120 min following consumption of glucose load.

次要结局

  • Improvement in fasting serum pro-inflammatory cytokine (IL-6, IL-1b, CRP, TNFa) levels after 4 weeks of drinking blueberry tea.(4 weeks)
  • Improvement in fasting serum albumin levels after 4 weeks of drinking blueberry tea..(4 weeks)
  • Improvement in large artery stiffness after 4 weeks of drinking blueberry tea.(4 weeks)
  • Improvement in Resting Blood Pressure (central and brachial blood pressure) after 4 weeks of drinking blueberry tea.(4 weeks)
  • Improvement in Hemoglobin A1c (HbA1c) levels after 4 weeks of drinking blueberry tea.(4 weeks.)
  • Improvement in fasting Serum Lipid (cholesterol, HDL, LDL,triglycerides) levels after 4 weeks of drinking blueberry tea.(4 weeks)
  • Fasting serum electrolytes (Na, K, Cl, HCO3).(4 weeks)
  • Improvement in resting Augmentation Index after 4 weeks of drinking blueberry tea.(4 weeks)

研究者

发起方
Menzies Institute for Medical Research
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michelle Keske

Senior Research Fellow

Menzies Institute for Medical Research

研究点 (2)

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