The Effect of Dietary Supplementation of Cinnamon (Cinnamon Cassia) on HbA1c, Blood Pressure and Serum Lipid Measurements in Patients With Type 2 Diabetes Mellitus: a Randomised Placebo Controlled, Double Blind Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
The aim of the study is to assess whether dietary supplementation of cinnamon (cinnamon cassia) has the potential to improve HbA1c, blood pressure and serum lipid measurements in patients with type 2 diabetes mellitus.
详细描述
The study will be conducted for 3 months (12 weeks) with 58 individuals diagnosed with type 2 diabetes mellitus. The randomisation will be carried out by using a randomisation list. Cinnamon bark (cinnamon cassia) and starch flour (placebo) capsules will be purchased from a local pharmaceutical company in UK; these are freely available for over the counter use. Each capsule contained either 500 mg of cinnamon powder or starch flour. The cinnamon and placebo (starch flour) capsules will be packaged in a non transparent plastic bags.
The patients will be randomly allocated into the two groups of:
Group 1: placebo control group Group 2: cinnamon group
Patients in both placebo and cinnamon groups will receive treatment similar to the treatment they would normally receive from their respective NHS or primary care trust for 12 weeks.
Data collection:
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with type 2 diabetes mellitus
- •Aged over 18 years, either sex
- •HbA1c level more than 7%
- •Patients treated only with oral anti-diabetic drugs or diet
排除标准
- •Patients with severe health problems including renal disease, liver disease, cardiovascular disease and other chronic ill health conditions
- •Patients with mental health problems
- •Patients treated with insulin therapy
- •Patients refused to give informed consent
- •Pregnant and lactating women
- •Patients taking cinnamon supplements and other herbal supplements known to be effective
研究组 & 干预措施
cinnamon
Subjects in this group will receive cinnamon capsules for 12 weeks period. The 2 g dose of cinnamon will be spread over the day as 500 mg (1 capsule) after breakfast, 1000 mg (2 capsules) after lunch and 500 mg (1 capsule) after dinner. The subjects will be instructed to take the capsules immediately after the meals.
干预措施: cinnamon 2g per day for 12 weeks (Dietary Supplement)
Control
Subjects in this group will receive placebo capsules (starch flour) for 12 weeks period. The 2 g dose of starch capsules will be spread over the day as 500 mg (1 capsule) after breakfast, 1000 mg (2 capsules) after lunch and 500 mg (1 capsule) after dinner. The subjects will be instructed to take the capsules immediately after the meals.
干预措施: cinnamon 2g per day for 12 weeks (Dietary Supplement)
结局指标
主要结局
HbA1c
时间窗: 3 months
次要结局
- Plasma glucose concentration Plasma lipid profiles (HDL, LDL, Triglycerides and total cholesterol) systolic and diastolic blood pressures. Body Mass Index. Waist circumference. Total calorie intake.(3 months)