ACTRN12617000361303尚未招募1 期
The effect of nutraceutical supplements (Thompson’s Super Bioflavonoid Complex 'Registered Trademark') on blood glucose levels in prediabetes and type 2 diabetes- A pilot study
niversity of Tasmania0 个研究点目标入组 100 人开始时间: 2017年3月8日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 25 Years 至 75 Years（—）
- 性别
- All
入选标准
- •For all participants
- •1.Have been clinically diagnosed with type 2 diabetes.
- •2.Aged between (25 and 75) years.
- •3.Lean, overweight or obese (BMI 19 to 35 kg/m2).
- •4.Have normal or controlled blood pressure.
- •5.Normotensive (seated brachial blood pressure less than 140/90 mmHg).
- •6.Have given signed informed consent to participate in the study.
- •7.Clinically diagnosed T2D on diet and lifestyle intervention or metformin only treatment (e.g. fasting plasma glucose equal or more than 7.0mM, HbA1c).
- •8.Willing to take nutraceutical supplements (Thompson’s Super Bioflavonoid Complex 'Registered Trademark' and Thompson’s Cholesterol Manager 'Registered Trademark'), for 12 weeks.
- •9.Negative pregnancy test for the woman during their reproductive life.
排除标准
- •For all participants
- •1. Age less than 25 yrs or more than 75 yrs
- •2. Morbidly obese with a BMI equal or more than 35 kg/m2
- •3. Not on diet and lifestyle or metformin only treatment for their diabetes (e.g. insulin injections, sulphonylureas, GLP-1 receptor agonists).
- •4. History of myocardial infarction or stroke
- •5. History of malignancy within past 5 years (except for non-melanoma skin cancers)
- •6. Identification of any medical condition requiring immediate therapeutic intervention
- •7. Uncontrolled hypertension (resting brachial blood pressure equal or more than 160/100 mmHg)
- •8. History of severe liver disease
- •9. History of drug or alcohol abuse
- •10. Elective major surgery during the course of the study
- •11. Pregnancy and/ or lactation
- •12. Currently consuming nutraceutical supplements (especially vitamin C and D)
- •13. Participation or intention to participate in another clinical research study during the study period.
- •14. Not willing to take nutraceutical supplements (Thompson’s Super Bioflavonoid Complex 'Registered Trademark' and Thompson’s Cholesterol Manager 'Registered Trademark'), for 12 weeks.
- •15. Positive pregnancy test for the woman during their reproductive life.
- •16. Participants with impaired renal function.
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