An Intervention Comparing Changes in the Plasma Glucose Profile Over a Three-hour Timespan in Persons With T2DM Following Caribbean Shake vs Glucerna Intake: A Double Blinded, Cross-over Design
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 主要终点
- Change in plasma glucose concentration post oral intake of shake
研究概览
简要总结
Following a meal, in nondiabetic individuals, blood glucose rises to peak at 1hr and returns to baseline in 2 - 3 hours. In T2DM, this peak is higher and prolonged. Meal plans for persons with T2DM should comprise evenly spaced, complex carbohydrate portions in order to avoid post-prandial glucose spikes. Researchers have developed an expanded line of Caribbean-flavoured, low-calorie meal-replacement shakes which have been formulated to match the macronutrient and caloric content of a commercially available brand. In this trial investigators aim to (1) examine the change in glucose levels post intake of Caribbean vs the commercially available brand and (2) to conduct a comparative sensory analysis of the two shakes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participants will be blinded to the intervention as the shakes will be given in unmarked containers - however as the flavours are very different it is likely that participants will be able to tell them apart. Data analysts will be blinded.
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of T2DM for any length of time,
- •last HbA1C (within the last 6 months) of < / = 8%
排除标准
- •On insulin for any length of time
结局指标
主要结局
Change in plasma glucose concentration post oral intake of shake
时间窗: 30 minutes, 60 minutes and 120 minutes post oral intake of shake
次要结局
- Sensory analysis of taste, texture, smell and appearance of shakes(within 1hour post oral intake of shake)
